Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Creighton University Medical Center | OTHER |
Not provided
Not provided
Not provided
The purpose of this study is to identify the best way to prevent bone loss in the first years after menopause. The HOPS study will compare bone loss at 12 months in women: 1) who take calcium and vitamin D only; 2) who take calcium and vitamin D plus the medication "risedronate"; or 3) who take calcium and vitamin D plus participate in bone-loading exercises. Our central hypothesis is that improvements in bone health will be greater in women randomized to bone-loading exercises with calcium and vitamin D compared to women who take calcium and vitamin D only or women who take calcium and vitamin D plus risedronate.
This randomized controlled trial (RCT) will compare changes after 12 months in bone structure, bone mineral density (BMD), and bone turnover in women with low bone mass who are within 5 years of menopause. Women will be randomized to one control and 2 treatment groups (n =103 per group): 1) calcium + vitamin D (CaD) alone (Control); 2) Bisphosphonate (BP) plus optimal CaD (Risedronate); and 3) a bone loading exercise program plus optimal CaD (Exercise). Our central hypothesis is that improvements in bone health will be greater in subjects randomized to the exercise group compared to subjects in either the control or risedronate groups. Specific Aims: Aims 1, 2, and 3 are to compare control, risedronate, and exercise group subjects on changes in bone structure at the tibia and hip (measured by pQCT and Hip Structural Analysis) (Aim 1) ; on changes in BMD at the total hip, femoral neck, and spine (Aim 2); and on changes in serum markers of bone formation and resorption (Aim 3). In addition, Aim 4 will explore relationships between adherence to exercise (% sessions attended) or adherence to risedronate (% pills taken) and changes in bone structure.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Women randomized to the control group will receive calcium and vitamin D intake for 12 months. Calcium intake will be determined by analyzing 3 day dietary intake of calcium at baseline and then prescribing calcium carbonate supplements to ensure women have ~1200 mg of calcium daily. Vitamin D intake will be determined using baseline measures of Serum 25 (OH) D. Subjects who have serum D levels of 30 ng/ml or greater will be prescribed 1,000 IU vitamin D3 daily; subjects with levels of 20-29 ng/ml will be prescribed 2,000 IU Vitamin D3; and subjects with levels of 10-19 ng/ml will be prescribed 3,000 IU Vitamin D3. |
|
| Risedronate | Experimental | Subjects in the risedronate group will take 35 mg of the bisphosphonate "risedronate" weekly for 12 months plus CaD. They will be asked to follow the protocol for administration of risedronate including taking the medication upon arising in the morning with an 8 ounce glass of water, remaining upright for at least 30 minutes, and having no oral intake except water for at least 30 minutes. |
|
| Exercise | Experimental | Subjects in the exercise group will participate in bone-loading exercises three times weekly in addition to taking CaD for 12 months. Women will exercise at community Young Men's Christian Association's fitness centers (YMCA) and exercises will be monitored by on-site Exercise Trainers. Exercises will consist of high-impact weight-bearing exercises (jogging with weighted vests) and resistance exercises for upper and lower extremities. Progressive increases in weight loads will be prescribed to provide maximal strength gains. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcium Carbonate | Drug | Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bone Strength Index of the Distal Tibia Based on Randomization to Control, Risedronate, or Exercise Group. | Change in Bone Strength Index (BSI) of the distal tibia based on randomization to Control, Risedronate, or Exercise group. BSI (mg2/mm4) at the 4% tibial site will be measured using peripheral quantitative computed tomography (pQCT). | Baseline, 6, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bone Mineral Density (BMD) at the Spine (L1-L4) Based on Randomization to Control, Risedronate, or Exercise Group. | Bone mineral density is the gold standard for diagnosis of low bone mass and osteoporosis and will be measured at the spine using Dual Energy X-ray Absorptiometry (DXA). | Baseline,6, and 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nancy L Waltman, PhD, APRN-NP | University of Nebraska | Principal Investigator |
| Laura Bilek, PT, PhD | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19252142 | Background | Bocalini DS, Serra AJ, dos Santos L, Murad N, Levy RF. Strength training preserves the bone mineral density of postmenopausal women without hormone replacement therapy. J Aging Health. 2009 Jun;21(3):519-27. doi: 10.1177/0898264309332839. Epub 2009 Feb 27. | |
| 12919708 | Background | Uusi-Rasi K, Kannus P, Cheng S, Sievanen H, Pasanen M, Heinonen A, Nenonen A, Halleen J, Fuerst T, Genant H, Vuori I. Effect of alendronate and exercise on bone and physical performance of postmenopausal women: a randomized controlled trial. Bone. 2003 Jul;33(1):132-43. doi: 10.1016/s8756-3282(03)00082-6. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Control | Women randomized to the control group will receive calcium and vitamin D intake for 12 months. Calcium intake will be determined by analyzing 3 day dietary intake of calcium at baseline and then prescribing calcium carbonate supplements to ensure women have ~1200 mg of calcium daily. Vitamin D intake will be determined using baseline measures of Serum 25 (OH) D. Subjects who have serum D levels of 30 ng/ml or greater will be prescribed 1,000 IU vitamin D3 daily; subjects with levels of 20-29 ng/ml will be prescribed 2,000 IU Vitamin D3; and subjects with levels of 10-19 ng/ml will be prescribed 3,000 IU Vitamin D3. Calcium Carbonate: Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement) Vitamin D3: Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml. |
| FG001 | Risedronate | Subjects in the risedronate group will take 35 mg of the bisphosphonate "risedronate" weekly for 12 months plus CaD. They will be asked to follow the protocol for administration of risedronate including taking the medication upon arising in the morning with an 8 ounce glass of water, remaining upright for at least 30 minutes, and having no oral intake except water for at least 30 minutes. Calcium Carbonate: Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement) Vitamin D3: Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml. Risedronate: Risedronate 35 mg orally will be ingested weekly by subjects in Risedronate group. |
| FG002 | Exercise | Subjects in the exercise group will participate in bone-loading exercises three times weekly in addition to taking CaD for 12 months. Women will exercise at community Young Men's Christian Association's fitness centers (YMCA) and exercises will be monitored by on-site Exercise Trainers. Exercises will consist of high-impact weight-bearing exercises (jogging with weighted vests) and resistance exercises for upper and lower extremities. Progressive increases in weight loads will be prescribed to provide maximal strength gains. Calcium Carbonate: Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement) Vitamin D3: Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml. Bone-loading exercises: Subjects will participate in bone loading exercises (weight-bearing and resistance) three times weekly at community YMCAs. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Control | Women randomized to the control group will receive calcium and vitamin D intake for 12 months. Calcium intake will be determined by analyzing 3 day dietary intake of calcium at baseline and then prescribing calcium carbonate supplements to ensure women have ~1200 mg of calcium daily. Vitamin D intake will be determined using baseline measures of Serum 25 (OH) D. Subjects who have serum D levels of 30 ng/ml or greater will be prescribed 1,000 IU vitamin D3 daily; subjects with levels of 20-29 ng/ml will be prescribed 2,000 IU Vitamin D3; and subjects with levels of 10-19 ng/ml will be prescribed 3,000 IU Vitamin D3. Calcium Carbonate: Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement) Vitamin D3: Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Bone Strength Index of the Distal Tibia Based on Randomization to Control, Risedronate, or Exercise Group. | Change in Bone Strength Index (BSI) of the distal tibia based on randomization to Control, Risedronate, or Exercise group. BSI (mg2/mm4) at the 4% tibial site will be measured using peripheral quantitative computed tomography (pQCT). | Intent-to-treat | Posted | Mean | Standard Deviation | mg^2/mm^4 | Baseline, 6, and 12 months |
|
12 months for each participant
At each study visit, participants were asked if they had any new health conditions or events. We had questionnaires that evaluated tolerance to the treatments which allowed us to communicate with those who experienced symptoms as a result of the intervention.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Women randomized to the control group will receive calcium and vitamin D intake for 12 months. Calcium intake will be determined by analyzing 3 day dietary intake of calcium at baseline and then prescribing calcium carbonate supplements to ensure women have ~1200 mg of calcium daily. Vitamin D intake will be determined using baseline measures of Serum 25 (OH) D. Subjects who have serum D levels of 30 ng/ml or greater will be prescribed 1,000 IU vitamin D3 daily; subjects with levels of 20-29 ng/ml will be prescribed 2,000 IU Vitamin D3; and subjects with levels of 10-19 ng/ml will be prescribed 3,000 IU Vitamin D3. Calcium Carbonate: Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement) Vitamin D3: Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Bilek | University of Nebraska Medical Center | 402-559-6923 | lbilek@unmc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 17, 2015 | Jun 23, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 27, 2020 | Nov 11, 2020 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| ID | Term |
|---|---|
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002119 | Calcium Carbonate |
| D016568 | Drugs, Generic |
| D002762 | Cholecalciferol |
| D000068296 | Risedronic Acid |
| ID | Term |
|---|---|
| D017610 | Calcium Compounds |
| D007287 | Inorganic Chemicals |
| D002254 | Carbonates |
| D002255 | Carbonic Acid |
Not provided
Not provided
Randomized to 3 treatment groups: Calcium + vitamin D only; risedronate and calcium + vitamin D; bone building exercises and calcium + vitamin D
Not provided
Not provided
Not provided
Not provided
|
| Vitamin D3 | Drug | Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml. |
|
|
| Risedronate | Drug | Risedronate 35 mg orally will be ingested weekly by subjects in Risedronate group. |
|
|
| Bone-loading exercises | Behavioral | Subjects will participate in bone loading exercises (weight-bearing and resistance) three times weekly at community YMCAs. |
|
| Change in Serum Measures of Bone Resorption (Serum NTx) Based on Randomization to Control, Risedronate, or Exercise Group. |
Bone turnover is the process of removing old bone (resorption by osteoclasts) and replacing it with new bone (formation by osteoblasts). Menopause results in a brief period (~5 years) of accelerated turnover with resorption far exceeding formation. In this study, resorption will be measured by Serum NTx. |
| Baseline, 6, 12 months |
| 17768587 | Background | Bergstrom I, Landgren B, Brinck J, Freyschuss B. Physical training preserves bone mineral density in postmenopausal women with forearm fractures and low bone mineral density. Osteoporos Int. 2008 Feb;19(2):177-83. doi: 10.1007/s00198-007-0445-6. Epub 2007 Sep 1. |
| 18382907 | Background | Dane C, Dane B, Cetin A, Erginbas M. Effect of risedronate on biochemical marker of bone resorption in postmenopausal women with osteoporosis or osteopenia. Gynecol Endocrinol. 2008 Apr;24(4):207-13. doi: 10.1080/09513590801895617. |
| 16283062 | Background | Cussler EC, Going SB, Houtkooper LB, Stanford VA, Blew RM, Flint-Wagner HG, Metcalfe LL, Choi JE, Lohman TG. Exercise frequency and calcium intake predict 4-year bone changes in postmenopausal women. Osteoporos Int. 2005 Dec;16(12):2129-41. doi: 10.1007/s00198-005-2014-1. Epub 2005 Nov 10. |
| 1874931 | Background | Elders PJ, Netelenbos JC, Lips P, van Ginkel FC, Khoe E, Leeuwenkamp OR, Hackeng WH, van der Stelt PF. Calcium supplementation reduces vertebral bone loss in perimenopausal women: a controlled trial in 248 women between 46 and 55 years of age. J Clin Endocrinol Metab. 1991 Sep;73(3):533-40. doi: 10.1210/jcem-73-3-533. |
| 18035193 | Background | Valimaki MJ, Farrerons-Minguella J, Halse J, Kroger H, Maroni M, Mulder H, Munoz-Torres M, Saaf M, Snorre Ofjord E. Effects of risedronate 5 mg/d on bone mineral density and bone turnover markers in late-postmenopausal women with osteopenia: a multinational, 24-month, randomized, double-blind, placebo-controlled, parallel-group, phase III trial. Clin Ther. 2007 Sep;29(9):1937-49. doi: 10.1016/j.clinthera.2007.09.017. |
| 17140871 | Background | Vainionpaa A, Korpelainen R, Sievanen H, Vihriala E, Leppaluoto J, Jamsa T. Effect of impact exercise and its intensity on bone geometry at weight-bearing tibia and femur. Bone. 2007 Mar;40(3):604-11. doi: 10.1016/j.bone.2006.10.005. Epub 2006 Nov 30. |
| 19802506 | Background | Waltman NL, Twiss JJ, Ott CD, Gross GJ, Lindsey AM, Moore TE, Berg K, Kupzyk K. The effect of weight training on bone mineral density and bone turnover in postmenopausal breast cancer survivors with bone loss: a 24-month randomized controlled trial. Osteoporos Int. 2010 Aug;21(8):1361-9. doi: 10.1007/s00198-009-1083-y. Epub 2009 Oct 3. |
| 10843171 | Background | Fogelman I, Ribot C, Smith R, Ethgen D, Sod E, Reginster JY. Risedronate reverses bone loss in postmenopausal women with low bone mass: results from a multinational, double-blind, placebo-controlled trial. BMD-MN Study Group. J Clin Endocrinol Metab. 2000 May;85(5):1895-900. doi: 10.1210/jcem.85.5.6603. |
| 12844212 | Background | Going S, Lohman T, Houtkooper L, Metcalfe L, Flint-Wagner H, Blew R, Stanford V, Cussler E, Martin J, Teixeira P, Harris M, Milliken L, Figueroa-Galvez A, Weber J. Effects of exercise on bone mineral density in calcium-replete postmenopausal women with and without hormone replacement therapy. Osteoporos Int. 2003 Aug;14(8):637-43. doi: 10.1007/s00198-003-1436-x. Epub 2003 Jul 3. |
| 12471325 | Background | Kemmler W, Engelke K, Lauber D, Weineck J, Hensen J, Kalender WA. Exercise effects on fitness and bone mineral density in early postmenopausal women: 1-year EFOPS results. Med Sci Sports Exerc. 2002 Dec;34(12):2115-23. doi: 10.1097/00005768-200212000-00038. |
| 19262975 | Background | Vainionpaa A, Korpelainen R, Vaananen HK, Haapalahti J, Jamsa T, Leppaluoto J. Effect of impact exercise on bone metabolism. Osteoporos Int. 2009 Oct;20(10):1725-33. doi: 10.1007/s00198-009-0881-6. Epub 2009 Mar 5. |
| 17724395 | Background | Klentrou P, Slack J, Roy B, Ladouceur M. Effects of exercise training with weighted vests on bone turnover and isokinetic strength in postmenopausal women. J Aging Phys Act. 2007 Jul;15(3):287-99. doi: 10.1123/japa.15.3.287. |
| 23208074 | Background | Prentice RL, Pettinger MB, Jackson RD, Wactawski-Wende J, Lacroix AZ, Anderson GL, Chlebowski RT, Manson JE, Van Horn L, Vitolins MZ, Datta M, LeBlanc ES, Cauley JA, Rossouw JE. Health risks and benefits from calcium and vitamin D supplementation: Women's Health Initiative clinical trial and cohort study. Osteoporos Int. 2013 Feb;24(2):567-80. doi: 10.1007/s00198-012-2224-2. Epub 2012 Dec 4. |
| 20148064 | Background | Somford MP, Geurts GF, den Teuling JW, Thomassen BJ, Draijer WF. Long-Term Alendronate Use Not without Consequences? Int J Rheumatol. 2009;2009:253432. doi: 10.1155/2009/253432. Epub 2010 Jan 27. |
| 19113923 | Background | Whyte MP. Atypical femoral fractures, bisphosphonates, and adult hypophosphatasia. J Bone Miner Res. 2009 Jun;24(6):1132-4. doi: 10.1359/jbmr.081253. |
| 15119056 | Background | Caulfield MP, Reitz RE. Biochemical markers of bone turnover and their utility in osteoporosis. MLO Med Lab Obs. 2004 Apr;36(4):34-7. No abstract available. |
| 16825677 | Background | Bischoff-Ferrari HA, Giovannucci E, Willett WC, Dietrich T, Dawson-Hughes B. Estimation of optimal serum concentrations of 25-hydroxyvitamin D for multiple health outcomes. Am J Clin Nutr. 2006 Jul;84(1):18-28. doi: 10.1093/ajcn/84.1.18. |
| 15886381 | Background | Bischoff-Ferrari HA, Willett WC, Wong JB, Giovannucci E, Dietrich T, Dawson-Hughes B. Fracture prevention with vitamin D supplementation: a meta-analysis of randomized controlled trials. JAMA. 2005 May 11;293(18):2257-64. doi: 10.1001/jama.293.18.2257. |
| 15758064 | Background | Ott SM. Long-term safety of bisphosphonates. J Clin Endocrinol Metab. 2005 Mar;90(3):1897-9. doi: 10.1210/jc.2005-0057. No abstract available. |
| 16405362 | Background | Schneider JP. Should bisphosphonates be continued indefinitely? An unusual fracture in a healthy woman on long-term alendronate. Geriatrics. 2006 Jan;61(1):31-3. No abstract available. |
| 12464707 | Background | Hamdy RC, Petak SM, Lenchik L; International Society for Clinical Densitometry Position Development Panel and Scientific Advisory Committee. Which central dual X-ray absorptiometry skeletal sites and regions of interest should be used to determine the diagnosis of osteoporosis? J Clin Densitom. 2002;5 Suppl:S11-8. doi: 10.1385/jcd:5:3s:s11. |
| 17521506 | Background | van der Linden JC, Weinans H. Effects of microarchitecture on bone strength. Curr Osteoporos Rep. 2007 Jun;5(2):56-61. doi: 10.1007/s11914-007-0003-3. |
| 17499038 | Background | Akhter MP, Lappe JM, Davies KM, Recker RR. Transmenopausal changes in the trabecular bone structure. Bone. 2007 Jul;41(1):111-6. doi: 10.1016/j.bone.2007.03.019. Epub 2007 Apr 10. |
| 17521505 | Background | Beck TJ. Extending DXA beyond bone mineral density: understanding hip structure analysis. Curr Osteoporos Rep. 2007 Jun;5(2):49-55. doi: 10.1007/s11914-007-0002-4. |
| 19335674 | Background | Twiss JJ, Waltman NL, Berg K, Ott CD, Gross GJ, Lindsey AM. An exercise intervention for breast cancer survivors with bone loss. J Nurs Scholarsh. 2009 Mar;41(1):20-7. doi: 10.1111/j.1547-5069.2009.01247.x. |
| 20061894 | Background | Management of osteoporosis in postmenopausal women: 2010 position statement of The North American Menopause Society. Menopause. 2010 Jan-Feb;17(1):25-54; quiz 55-6. doi: 10.1097/gme.0b013e3181c617e6. |
| 17031008 | Background | Lappe JM, Davies KM, Travers-Gustafson D, Heaney RP. Vitamin D status in a rural postmenopausal female population. J Am Coll Nutr. 2006 Oct;25(5):395-402. doi: 10.1080/07315724.2006.10719551. |
| 15050906 | Background | Borah B, Dufresne TE, Chmielewski PA, Johnson TD, Chines A, Manhart MD. Risedronate preserves bone architecture in postmenopausal women with osteoporosis as measured by three-dimensional microcomputed tomography. Bone. 2004 Apr;34(4):736-46. doi: 10.1016/j.bone.2003.12.013. |
| 21779818 | Background | Kanis JA, Hans D, Cooper C, Baim S, Bilezikian JP, Binkley N, Cauley JA, Compston JE, Dawson-Hughes B, El-Hajj Fuleihan G, Johansson H, Leslie WD, Lewiecki EM, Luckey M, Oden A, Papapoulos SE, Poiana C, Rizzoli R, Wahl DA, McCloskey EV; Task Force of the FRAX Initiative. Interpretation and use of FRAX in clinical practice. Osteoporos Int. 2011 Sep;22(9):2395-411. doi: 10.1007/s00198-011-1713-z. Epub 2011 Jul 21. |
| 21694556 | Background | Garber CE, Blissmer B, Deschenes MR, Franklin BA, Lamonte MJ, Lee IM, Nieman DC, Swain DP; American College of Sports Medicine. American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Med Sci Sports Exerc. 2011 Jul;43(7):1334-59. doi: 10.1249/MSS.0b013e318213fefb. |
| 17291843 | Background | Maddalozzo GF, Widrick JJ, Cardinal BJ, Winters-Stone KM, Hoffman MA, Snow CM. The effects of hormone replacement therapy and resistance training on spine bone mineral density in early postmenopausal women. Bone. 2007 May;40(5):1244-51. doi: 10.1016/j.bone.2006.12.059. Epub 2006 Dec 29. |
| 22581292 | Background | Ashe MC, Gorman E, Khan KM, Brasher PM, Cooper DM, McKay HA, Liu-Ambrose T. Does frequency of resistance training affect tibial cortical bone density in older women? A randomized controlled trial. Osteoporos Int. 2013 Feb;24(2):623-32. doi: 10.1007/s00198-012-2000-3. Epub 2012 May 12. |
| 34519832 | Result | Waltman N, Kupzyk KA, Flores LE, Mack LR, Lappe JM, Bilek LD. Bone-loading exercises versus risedronate for the prevention of osteoporosis in postmenopausal women with low bone mass: a randomized controlled trial. Osteoporos Int. 2022 Feb;33(2):475-486. doi: 10.1007/s00198-021-06083-2. Epub 2021 Sep 14. |
| 27576310 | Derived | Bilek LD, Waltman NL, Lappe JM, Kupzyk KA, Mack LR, Cullen DM, Berg K, Langel M, Meisinger M, Portelli-Trinidad A, Lang M. Protocol for a randomized controlled trial to compare bone-loading exercises with risedronate for preventing bone loss in osteopenic postmenopausal women. BMC Womens Health. 2016 Aug 30;16(1):59. doi: 10.1186/s12905-016-0339-x. |
| BG001 | Risedronate | Subjects in the risedronate group will take 35 mg of the bisphosphonate "risedronate" weekly for 12 months plus CaD. They will be asked to follow the protocol for administration of risedronate including taking the medication upon arising in the morning with an 8 ounce glass of water, remaining upright for at least 30 minutes, and having no oral intake except water for at least 30 minutes. Calcium Carbonate: Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement) Vitamin D3: Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml. Risedronate: Risedronate 35 mg orally will be ingested weekly by subjects in Risedronate group. |
| BG002 | Exercise | Subjects in the exercise group will participate in bone-loading exercises three times weekly in addition to taking CaD for 12 months. Women will exercise at community Young Men's Christian Association's fitness centers (YMCA) and exercises will be monitored by on-site Exercise Trainers. Exercises will consist of high-impact weight-bearing exercises (jogging with weighted vests) and resistance exercises for upper and lower extremities. Progressive increases in weight loads will be prescribed to provide maximal strength gains. Calcium Carbonate: Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement) Vitamin D3: Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml. Bone-loading exercises: Subjects will participate in bone loading exercises (weight-bearing and resistance) three times weekly at community YMCAs. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Family History of Low Bone Mass or Osteoporosis | Number of participants with a positive family history of osteoporosis. | Count of Participants | Participants |
|
| OG001 | Risedronate | Subjects in the risedronate group will take 35 mg of the bisphosphonate "risedronate" weekly for 12 months plus CaD. They will be asked to follow the protocol for administration of risedronate including taking the medication upon arising in the morning with an 8 ounce glass of water, remaining upright for at least 30 minutes, and having no oral intake except water for at least 30 minutes. Calcium Carbonate: Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement) Vitamin D3: Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml. Risedronate: Risedronate 35 mg orally will be ingested weekly by subjects in Risedronate group. |
| OG002 | Exercise | Subjects in the exercise group will participate in bone-loading exercises three times weekly in addition to taking CaD for 12 months. Women will exercise at community Young Men's Christian Association's fitness centers (YMCA) and exercises will be monitored by on-site Exercise Trainers. Exercises will consist of high-impact weight-bearing exercises (jogging with weighted vests) and resistance exercises for upper and lower extremities. Progressive increases in weight loads will be prescribed to provide maximal strength gains. Calcium Carbonate: Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement) Vitamin D3: Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml. Bone-loading exercises: Subjects will participate in bone loading exercises (weight-bearing and resistance) three times weekly at community YMCAs. |
|
|
|
| Secondary | Change in Bone Mineral Density (BMD) at the Spine (L1-L4) Based on Randomization to Control, Risedronate, or Exercise Group. | Bone mineral density is the gold standard for diagnosis of low bone mass and osteoporosis and will be measured at the spine using Dual Energy X-ray Absorptiometry (DXA). | Intent to treat analysis | Posted | Mean | Standard Deviation | g/cm^2 | Baseline,6, and 12 months |
|
|
|
|
| Secondary | Change in Serum Measures of Bone Resorption (Serum NTx) Based on Randomization to Control, Risedronate, or Exercise Group. | Bone turnover is the process of removing old bone (resorption by osteoclasts) and replacing it with new bone (formation by osteoblasts). Menopause results in a brief period (~5 years) of accelerated turnover with resorption far exceeding formation. In this study, resorption will be measured by Serum NTx. | Intention to treat for persons who had valid data at baseline | Posted | Mean | Standard Deviation | nanoMolar Bone Collagen Equivalents/L | Baseline, 6, 12 months |
|
|
|
|
| 0 |
| 93 |
| 0 |
| 93 |
| 9 |
| 93 |
| EG001 | Risedronate | Subjects in the risedronate group will take 35 mg of the bisphosphonate "risedronate" weekly for 12 months plus CaD. They will be asked to follow the protocol for administration of risedronate including taking the medication upon arising in the morning with an 8 ounce glass of water, remaining upright for at least 30 minutes, and having no oral intake except water for at least 30 minutes. Calcium Carbonate: Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement) Vitamin D3: Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml. Risedronate: Risedronate 35 mg orally will be ingested weekly by subjects in Risedronate group. | 0 | 91 | 0 | 91 | 30 | 91 |
| EG002 | Exercise | Subjects in the exercise group will participate in bone-loading exercises three times weekly in addition to taking CaD for 12 months. Women will exercise at community Young Men's Christian Association's fitness centers (YMCA) and exercises will be monitored by on-site Exercise Trainers. Exercises will consist of high-impact weight-bearing exercises (jogging with weighted vests) and resistance exercises for upper and lower extremities. Progressive increases in weight loads will be prescribed to provide maximal strength gains. Calcium Carbonate: Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement) Vitamin D3: Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml. Bone-loading exercises: Subjects will participate in bone loading exercises (weight-bearing and resistance) three times weekly at community YMCAs. | 0 | 92 | 0 | 92 | 4 | 92 |
| Gi disturbances | Gastrointestinal disorders | Systematic Assessment |
|
| muscle or joint pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Chest Pain or Dizziness | Cardiac disorders | Systematic Assessment |
|
Not provided
Not provided
| D017554 |
| Carbon Compounds, Inorganic |
| D008903 | Minerals |
| D004364 | Pharmaceutical Preparations |
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| 6 Months |
|
|
| 12 Months |
|
|
|
| 12 Months |
|