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| ID | Type | Description | Link |
|---|---|---|---|
| 2009P000525 |
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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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The aim of this study is to determine whether denosumab (an FDA-approved osteoporosis therapy), in combination with teriparatide (an FDA-approved osteoporosis therapy), will increase bone mineral density more than either one alone in postmenopausal osteoporotic women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| denosumab ONLY | Experimental |
| |
| teriparatide (Forteo®) ONLY | Experimental |
| |
| denosumab and teriparatide (Forteo®) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| denosumab | Drug | denosumab: 60 mg SC every 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Spine Bone Density From Baseline to 2 Years | Baseline and 2 years |
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Inclusion Criteria:
Must satisfy A and B and C and D below:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Z Leder, MD | Massachusetts General Hospital | Principal Investigator |
| Robert M Neer, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11346808 | Background | Neer RM, Arnaud CD, Zanchetta JR, Prince R, Gaich GA, Reginster JY, Hodsman AB, Eriksen EF, Ish-Shalom S, Genant HK, Wang O, Mitlak BH. Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med. 2001 May 10;344(19):1434-41. doi: 10.1056/NEJM200105103441904. | |
| 14500804 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Denosumab ONLY | denosumab: denosumab: 60 mg SC every 6 months |
| FG001 | Teriparatide (Forteo®) ONLY | teriparatide: teriparatide: 20 mcg SC QD |
| FG002 | Denosumab and Teriparatide (Forteo®) | denosumab: denosumab: 60 mg SC every 6 months teriparatide: teriparatide: 20 mcg SC QD |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Year 1 |
| |||||||||||||
| Year 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Denosumab ONLY | denosumab: denosumab: 60 mg SC every 6 months |
| BG001 | Teriparatide (Forteo®) ONLY | teriparatide: teriparatide: 20 mcg SC QD |
| 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 Spine Bone Density From Baseline to 2 Years | Posted | Mean | Standard Error | percent change | Baseline and 2 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Denosumab ONLY | denosumab: denosumab: 60 mg SC every 6 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Natalie David | Massachusetts General Hospital | ndavid2@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069448 | Denosumab |
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| teriparatide | Drug | teriparatide: 20 mcg SC QD |
|
|
| Black DM, Greenspan SL, Ensrud KE, Palermo L, McGowan JA, Lang TF, Garnero P, Bouxsein ML, Bilezikian JP, Rosen CJ; PaTH Study Investigators. The effects of parathyroid hormone and alendronate alone or in combination in postmenopausal osteoporosis. N Engl J Med. 2003 Sep 25;349(13):1207-15. doi: 10.1056/NEJMoa031975. Epub 2003 Sep 20. |
| 14500805 | Background | Finkelstein JS, Hayes A, Hunzelman JL, Wyland JJ, Lee H, Neer RM. The effects of parathyroid hormone, alendronate, or both in men with osteoporosis. N Engl J Med. 2003 Sep 25;349(13):1216-26. doi: 10.1056/NEJMoa035725. Epub 2003 Sep 20. |
| 11341338 | Background | Cosman F, Nieves J, Woelfert L, Formica C, Gordon S, Shen V, Lindsay R. Parathyroid hormone added to established hormone therapy: effects on vertebral fracture and maintenance of bone mass after parathyroid hormone withdrawal. J Bone Miner Res. 2001 May;16(5):925-31. doi: 10.1359/jbmr.2001.16.5.925. |
| 11564687 | Background | Kostenuik PJ, Capparelli C, Morony S, Adamu S, Shimamoto G, Shen V, Lacey DL, Dunstan CR. OPG and PTH-(1-34) have additive effects on bone density and mechanical strength in osteopenic ovariectomized rats. Endocrinology. 2001 Oct;142(10):4295-304. doi: 10.1210/endo.142.10.8437. |
| 9568710 | Background | Lacey DL, Timms E, Tan HL, Kelley MJ, Dunstan CR, Burgess T, Elliott R, Colombero A, Elliott G, Scully S, Hsu H, Sullivan J, Hawkins N, Davy E, Capparelli C, Eli A, Qian YX, Kaufman S, Sarosi I, Shalhoub V, Senaldi G, Guo J, Delaney J, Boyle WJ. Osteoprotegerin ligand is a cytokine that regulates osteoclast differentiation and activation. Cell. 1998 Apr 17;93(2):165-76. doi: 10.1016/s0092-8674(00)81569-x. |
| 9520411 | Background | Yasuda H, Shima N, Nakagawa N, Yamaguchi K, Kinosaki M, Mochizuki S, Tomoyasu A, Yano K, Goto M, Murakami A, Tsuda E, Morinaga T, Higashio K, Udagawa N, Takahashi N, Suda T. Osteoclast differentiation factor is a ligand for osteoprotegerin/osteoclastogenesis-inhibitory factor and is identical to TRANCE/RANKL. Proc Natl Acad Sci U S A. 1998 Mar 31;95(7):3597-602. doi: 10.1073/pnas.95.7.3597. |
| 18381571 | Background | Bone HG, Bolognese MA, Yuen CK, Kendler DL, Wang H, Liu Y, San Martin J. Effects of denosumab on bone mineral density and bone turnover in postmenopausal women. J Clin Endocrinol Metab. 2008 Jun;93(6):2149-57. doi: 10.1210/jc.2007-2814. Epub 2008 Apr 1. |
| 18539106 | Background | Miller PD, Bolognese MA, Lewiecki EM, McClung MR, Ding B, Austin M, Liu Y, San Martin J. Effect of denosumab on bone density and turnover in postmenopausal women with low bone mass after long-term continued, discontinued, and restarting of therapy: a randomized blinded phase 2 clinical trial. Bone. 2008 Aug;43(2):222-229. doi: 10.1016/j.bone.2008.04.007. Epub 2008 Apr 26. |
| 17164314 | Background | Antoniucci DM, Sellmeyer DE, Bilezikian JP, Palermo L, Ensrud KE, Greenspan SL, Black DM. Elevations in serum and urinary calcium with parathyroid hormone (1-84) with and without alendronate for osteoporosis. J Clin Endocrinol Metab. 2007 Mar;92(3):942-7. doi: 10.1210/jc.2006-1788. Epub 2006 Dec 12. |
| 26964731 | Derived | Tsai JN, Uihlein AV, Burnett-Bowie SM, Neer RM, Derrico NP, Lee H, Bouxsein ML, Leder BZ. Effects of Two Years of Teriparatide, Denosumab, or Both on Bone Microarchitecture and Strength (DATA-HRpQCT study). J Clin Endocrinol Metab. 2016 May;101(5):2023-30. doi: 10.1210/jc.2016-1160. Epub 2016 Mar 10. |
| 26144908 | Derived | Leder BZ, Tsai JN, Uihlein AV, Wallace PM, Lee H, Neer RM, Burnett-Bowie SA. Denosumab and teriparatide transitions in postmenopausal osteoporosis (the DATA-Switch study): extension of a randomised controlled trial. Lancet. 2015 Sep 19;386(9999):1147-55. doi: 10.1016/S0140-6736(15)61120-5. Epub 2015 Jul 2. |
| 24420643 | Derived | Yu EW, Kumbhani R, Siwila-Sackman E, DeLelys M, Preffer FI, Leder BZ, Wu JY. Teriparatide (PTH 1-34) treatment increases peripheral hematopoietic stem cells in postmenopausal women. J Bone Miner Res. 2014 Jun;29(6):1380-6. doi: 10.1002/jbmr.2171. |
| 23683600 | Derived | Tsai JN, Uihlein AV, Lee H, Kumbhani R, Siwila-Sackman E, McKay EA, Burnett-Bowie SA, Neer RM, Leder BZ. Teriparatide and denosumab, alone or combined, in women with postmenopausal osteoporosis: the DATA study randomised trial. Lancet. 2013 Jul 6;382(9886):50-6. doi: 10.1016/S0140-6736(13)60856-9. Epub 2013 May 15. |
| NOT COMPLETED |
|
| BG002 | Denosumab and Teriparatide (Forteo®) | denosumab: denosumab: 60 mg SC every 6 months teriparatide: teriparatide: 20 mcg SC QD |
| 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 |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body-mass index | Mean | Standard Deviation | kg/m^2 |
|
| History of fragility fracture | Count of Participants | Participants |
|
| Previous oral bisphosphonate use | Count of Participants | Participants |
|
| 25-Hydroxyvitamin D (ng/mL) | Mean | Standard Deviation | ng/mL |
|
| Alkaline phosphatase concentration in serum (U/L) | Mean | Standard Deviation | U/L |
|
| Osteocalcin (ng/mL) | Mean | Standard Deviation | ng/mL |
|
| Serum amino-terminal propeptide of type 1 procollagen (P1NP) (µg/L) | Mean | Standard Deviation | µg/L |
|
| Serum β-C-terminal telopeptide of type 1 collagen (CTX) (ng/mL) | Mean | Standard Deviation | ng/mL |
|
| DXA Bone Density (g/cm^2) (Posterior-anterior lumbar spine) | Mean | Standard Deviation | g/cm^2 |
|
| DXA Bone Density (g/cm^2) (Femoral neck) | Mean | Standard Deviation | g/cm^2 |
|
| DXA Bone Density (g/cm^2) (Total hip) | Mean | Standard Deviation | g/cm^2 |
|
| DXA Bone Density (g/cm^2) (Distal 1/3 of the radius shaft) | Mean | Standard Deviation | g/cm^2 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 1 |
| 33 |
| 4 |
| 33 |
| EG001 | Teriparatide (Forteo®) ONLY | teriparatide: teriparatide: 20 mcg SC QD | 2 | 31 | 5 | 31 |
| EG002 | Denosumab and Teriparatide (Forteo®) | denosumab: denosumab: 60 mg SC every 6 months teriparatide: teriparatide: 20 mcg SC QD | 1 | 30 | 4 | 30 |
| Melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Heart attack | Cardiac disorders | Non-systematic Assessment |
|
| Reactions at injection site | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hypercalcemia | Endocrine disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |