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Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women

05:14 EDT 23rd April 2014 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Premenopause

Intervention

Teriparatide (PTH 1-34), Teriparatide (PTH 1-34)

Location

Columbia University Medical Center
New York
New York
United States
10032

Status

Recruiting

Source

Columbia University

Results (where available)

View Results

Links

Medical and Biotech [MESH] Definitions

A polypeptide that consists of the 1-34 amino-acid fragment of human PARATHYROID HORMONE, the biologically active N-terminal region. The acetate form is given by intravenous infusion in the differential diagnosis of HYPOPARATHYROIDISM and PSEUDOHYPOPARATHYROIDISM. (Reynolds JEF(Ed): Martindale: The Extra Pharmacopoeia (electronic version). Micromedex, Inc, Englewood, CO, 1995)

The period before MENOPAUSE. In premenopausal women, the climacteric transition from full sexual maturity to cessation of ovarian cycle takes place between the age of late thirty and early fifty.

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PubMed Articles [25 Associated PubMed Articles listed on BioPortfolio]

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Introduction. Bone disease is a common complication of cystic fibrosis (CF). To date, there have been no reports on the effectiveness of teriparatide, recombinant human parathyroid hormone, to treat C...

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New Development in Osteoporosis Treatment. Daily subcutaneous injection of teriparatide : the progress and current issues.

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