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Sponsors and Collaborators: |
Columbia University Eli Lilly and Company |
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Information provided by: | Columbia University |
ClinicalTrials.gov Identifier: | NCT00697463 |
Idiopathic osteoporosis (IOP) is an uncommon disorder in which otherwise healthy young individuals sustain one or more low-trauma fractures. Teriparatide [PTH(1-34)], which is FDA approved for treatment of osteoporosis in men and postmenopausal women, works by stimulating bone formation. We hypothesize that teriparatide will significantly increase bone density (BMD) and improve bone structure in premenopausal women with IOP.
Condition | Intervention | Phase |
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Premenopause Low Bone Density Fracture Osteoporosis |
Drug: Teriparatide (PTH 1-34) |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Teriparatide for the Treatment of Idiopathic Osteoporosis in Premenopausal Women |
Estimated Enrollment: | 27 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Each subject will receive 20 micrograms of teriparatide subcutaneously daily.
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Drug: Teriparatide (PTH 1-34)
20 micrograms subcutaneous injection daily for 18 months
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2: Active Comparator
Each subject will receive a daily injection of 20 micrograms subcutaneously.
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Drug: Teriparatide (PTH 1-34)
Daily injection of 20 micrograms subcutaneously for 4 weeks
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Idiopathic osteoporosis (IOP) is an uncommon disorder in which otherwise healthy young individuals sustain one or more low-trauma fractures. In our studies of IOP in men, histomorphometric indices of bone formation are depressed, and affected men respond to PTH(1-34) with robust increases in lumbar spine (LS) bone mineral density (BMD). We are now beginning the third year of an R01 (AR4989603) investigating the etiology and pathogenesis, as well as the histomorphometric and bone microarchitectural features of IOP in premenopausal women. We have found evidence of markedly decreased bone formation and microarchitectural deterioration with decreased mechanical competence/strength.
Teriparatide [PTH(1-34)] is an anabolic agent that stimulates bone formation and improves bone microarchitecture. Based upon our findings, we hypothesize that teriparatide will significantly increase BMD and improve microarchitecture in premenopausal women with IOP.
We will test this hypothesis in an open-label study of carefully characterized premenopausal women with IOP who are participating in our NIH-funded study and who have fragility fractures or very low bone density. Participants in the study will receive 18 months of teriparatide and the effects on BMD and microstructure, bone mechanical competence, and bone turnover will be assessed. In order to assess whether teriparatide stimulates bone formation to the same extent in women with IOP as it does in normal women, we will compare the short-term changes (2 and 4 weeks) in biochemical markers of bone formation in response to teriparatide between women with IOP and normal women who are participating in our NIH-funded study as controls.
Ages Eligible for Study: | 20 Years to 48 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Halley F Eisenberg, MPH | 212-305-7225 | hfe2101@columbia.edu |
Contact: Shannon Kokolus, BS | 212-305-7225 | sk2990@columbia.edu |
United States, New York | |
Columbia University Medical Center | Recruiting |
New York, New York, United States, 10032 |
Principal Investigator: | Elizabeth Shane, MD | Columbia University Medical Center |
Study Director: | Adi Cohen, MD | Columbia University Medical Center |
Responsible Party: | Columbia University Medical Center ( Elizabeth Shane, MD ) |
Study ID Numbers: | AAAC6871 |
Study First Received: | June 11, 2008 |
Last Updated: | June 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00697463 |
Health Authority: | United States: Institutional Review Board |
Teriparatide Forteo Osteopenia Osteoporosis |
Fracture Low Bone Density Premenopausal women |
Musculoskeletal Diseases Teriparatide Fractures, Bone |
Osteoporosis Bone Diseases, Metabolic Bone Diseases |
Physiological Effects of Drugs Bone Density Conservation Agents Pharmacologic Actions |