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The aim of the study is to assess the relative antiresorptive properties of 2 osteoporosis medications when combined with teriparatide.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Denosumab 60mg subcutaneous injection | Active Comparator | Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit. |
|
| Alendronate 70mg weekly x 8 weeks | Active Comparator | Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriparatide 40-mcg subcutaneous injection | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone Turnover Marker (Blood Sample) | The primary outcome was the between-group difference in the teriparatide-induced change in serum c-telopeptide from baseline to week 8. | 8 weeks |
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Inclusion Criteria:
Must satisfy A and B and C below:
A. Women aged 45+
B. Postmenopausal
C. Osteoporotic with high risk of fracture
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20814967 | Background | Cosman F, Eriksen EF, Recknor C, Miller PD, Guanabens N, Kasperk C, Papanastasiou P, Readie A, Rao H, Gasser JA, Bucci-Rechtweg C, Boonen S. Effects of intravenous zoledronic acid plus subcutaneous teriparatide [rhPTH(1-34)] in postmenopausal osteoporosis. J Bone Miner Res. 2011 Mar;26(3):503-11. doi: 10.1002/jbmr.238. | |
| 14500805 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Denosumab 60mg Subcutaneous Injection | Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit. Teriparatide 40-mcg subcutaneous injection |
| FG001 | Alendronate 70mg Weekly x 8 Weeks | Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit. Teriparatide 40-mcg subcutaneous injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Denosumab 60mg Subcutaneous Injection | Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit. Teriparatide 40-mcg subcutaneous injection |
| BG001 | Alendronate 70mg Weekly x 8 Weeks |
| 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 | Bone Turnover Marker (Blood Sample) | The primary outcome was the between-group difference in the teriparatide-induced change in serum c-telopeptide from baseline to week 8. | Posted | Mean | Standard Deviation | percentage of change in CTX | 8 weeks |
|
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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 60mg Subcutaneous Injection | Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit. Teriparatide 40-mcg subcutaneous injection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lightheadedness | Endocrine disorders | One subject experienced lightheadedness 3 hours after the first teriparatide injection |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joy Tsai | Massachusetts General Hospital | 617-726-6723 | jntsai@mgh.harvard.edu |
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| ID | Term |
|---|---|
| D015663 | Osteoporosis, Postmenopausal |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D019379 | Teriparatide |
| D007279 | Injections, Subcutaneous |
| D000069448 | Denosumab |
| D019386 | Alendronate |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Denosumab Injection | Drug | One-time Denosumab injection |
|
| Alendronate Oral Tablet | Drug | weekly alendronate for 8 weeks |
|
| 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. |
| 16093465 | Background | Cosman F, Nieves J, Zion M, Woelfert L, Luckey M, Lindsay R. Daily and cyclic parathyroid hormone in women receiving alendronate. N Engl J Med. 2005 Aug 11;353(6):566-75. doi: 10.1056/NEJMoa050157. |
| 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. |
| 20164296 | Background | Finkelstein JS, Wyland JJ, Lee H, Neer RM. Effects of teriparatide, alendronate, or both in women with postmenopausal osteoporosis. J Clin Endocrinol Metab. 2010 Apr;95(4):1838-45. doi: 10.1210/jc.2009-1703. Epub 2010 Feb 17. |
| 25933031 | Derived | Tsai JN, Zhu Y, Foley K, Lee H, Burnett-Bowie SA, Neer RM, Leder BZ. Comparative Resistance to Teriparatide-Induced Bone Resorption With Denosumab or Alendronate. J Clin Endocrinol Metab. 2015 Jul;100(7):2718-23. doi: 10.1210/jc.2015-1541. Epub 2015 May 1. |
Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.
Teriparatide 40-mcg subcutaneous injection
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 1 |
| 12 |
| 0 |
| 12 |
| EG001 | Alendronate 70mg Weekly x 8 Weeks | Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit. Teriparatide 40-mcg subcutaneous injection | 1 | 13 | 0 | 13 |
|
| Syncope | Endocrine disorders | One subject experienced lightheadedness and syncope 3 hours after the first teriparatide injection |
|
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| D009750 |
| Nutritional and Metabolic Diseases |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |