Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women (IOPForteo)
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|ClinicalTrials.gov Identifier: NCT00697463|
Recruitment Status : Completed
First Posted : June 13, 2008
Results First Posted : July 26, 2018
Last Update Posted : July 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Menopause Fracture Osteoporosis||Drug: Teriparatide (PTH 1-34)||Phase 2 Phase 3|
Idiopathic osteoporosis (IOP) is an uncommon disorder in which otherwise healthy young individuals sustain one or more low-trauma fractures. In 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). This is the beginning of 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. There is 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 on findings, the investigators hypothesize that teriparatide will significantly increase BMD and improve microarchitecture in premenopausal women with IOP.
This is an open-label study of carefully characterized premenopausal women with IOP who are participating in a NIH-funded study and who have fragility fractures or very low bone density. Participants in the study will receive 18-24 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, the study 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 another NIH-funded study as controls.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Teriparatide for the Treatment of Idiopathic Osteoporosis in Premenopausal Women|
|Actual Study Start Date :||August 20, 2008|
|Actual Primary Completion Date :||January 3, 2012|
|Actual Study Completion Date :||January 3, 2012|
Experimental: Women with Idiopathic osteoporosis (IOP)
Each subject will receive 20 micrograms of Teriparatide (PTH 1-34) subcutaneously daily for 18 -24 months
Drug: Teriparatide (PTH 1-34)
20 micrograms subcutaneous injection daily
Other Name: Forteo
- Change in Lumbar Spine Bone Density by Dual Energy X-ray Absorptiometry (DXA) [ Time Frame: Baseline, Month 18 or 24 reported ]Areal BMD at the lumbar spine was measured by dual energy x-ray absorptiometry (DXA) at baseline and at 6, 12, 18, and 24 months, if possible.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00697463
|United States, Nebraska|
|Omaha, Nebraska, United States, 68131|
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Elizabeth Shane, MD||Columbia University|
|Study Director:||Adi Cohen, MD||Columbia University|