drugset / Trial / NCT00000427
Effects of Parathyroid Hormone in Men With Osteoporosis
Phase 3
Completed
81 enrolled
Massachusetts General Hospital
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Alendronate is a drug that blocks or reduces bone loss, while parathyroid hormone (PTH) stimulates the formation of new bone. The purpose of this study is to compare the bone-building effects of PTH alone, alendronate alone, and both PTH and alendronate in men with osteoporosis over a two-and-a-half year period.
Timeline
- Start
- 1999-09
- Primary completion
- 2005-10
- Completion
- 2005-10
Outcome
Met primary endpoint
paper In men receiving teriparatide monotherapy (group 2), levels of all bone turnover markers increased markedly PMID 16684825 ↗
paper Changes in each marker were significantly different between groups 1 and 2 (all P values < 0.001) PMID 16684825 ↗
Publications
- Background Finkelstein JS, Klibanski A, Schaefer EH, Hornstein MD, Schiff I, Neer RM. Parathyroid hormone for the prevention of bone loss induced by estrogen deficiency. N Engl J Med. 1994 Dec 15;331(24):1618-23. doi: 10.1056/NEJM199412153312404.
- 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.
- Results Finkelstein JS, Leder BZ, Burnett SM, Wyland JJ, Lee H, de la Paz AV, Gibson K, Neer RM. Effects of teriparatide, alendronate, or both on bone turnover in osteoporotic men. J Clin Endocrinol Metab. 2006 Aug;91(8):2882-7. doi: 10.1210/jc.2006-0190. Epub 2006 May 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alendronic Acid | Small molecule | 10 mg | Oral |
| Subject | Parathyroid Hormone | Protein / enzyme biologic | 37 ug | Subcutaneous |