Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women

03:42 EDT 5th July 2015 | 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

Clinical Trials [49 Associated Clinical Trials listed on BioPortfolio]

A Study for the Transdermal Application of Teriparatide

The primary purpose of this study is to help answer the following research questions: 1. How teriparatide given using a skin patch (transferred through the skin using the ViaDerm T...

Combined Use of Teriparatide and Raloxifene in Postmenopausal Women With Osteoporosis

The purpose of this study is to compare treatment with both teriparatide and raloxifene with teriparatide alone. The study will evaluate any side effects that may be associated with the t...

Phase 3 Clinical Trial of Teriparatide in Japan

To evaluate the efficacy of teriparatide based on measurements of bone mineral density at lumbar spine

Efficacy Study of Zoledronic Acid and Teriparatide Combination Therapy in Women With Osteoporosis

The purpose of this study is to assess the effects of zoledronic acid administered at the same time with teriparatide compared to zoledronic acid alone and teriparatide alone on bone mine...

Clinical Trial of Teriparatide in Japan

The purpose of this study is to assess the Efficacy and Safety of Teriparatide in Japanese Postmenopausal Women with Osteoporosis.

PubMed Articles [14 Associated PubMed Articles listed on BioPortfolio]

Comparative Resistance to Teriparatide-Induced Bone Resorption with Denosumab or Alendronate.

In postmenopausal osteoporotic women, denosumab fully inhibits teriparatide-induced bone resorption at approved doses. This property of denosumab is distinct from that of alendronate and likely contri...

Daily or Cyclical Teriparatide Treatment in Women with Osteoporosis on no Prior Therapy and Women on Alendronate.

Intermittent 3-month cyclic adminstation might optimize the anabolic potential of teriparatide (TPTD).

Osteoporotic Fractures and Associated Hospitalizations among Patients Treated with Teriparatide Compared to a Matched Cohort of Patients not Treated with Teriparatide.

Compare fractures and fracture-related resource utilization (RU) among patients with a recent fracture and treated with teriparatide (TPTD) to a matched cohort of patients not treated with TPTD (non-T...

Three-Times-Weekly Administration of Teriparatide Improves Vertebral and Peripheral Bone Density, Microarchitecture, and Mechanical Properties Without Accelerating Bone Resorption in Ovariectomized Rats.

Daily and weekly administration of teriparatide (PTH1-34) reduces the risk of osteoporotic bone fractures. However, their effects on markers of bone formation and bone resorption differ. These results...

Impact of Teriparatide on Quality of Life in Osteoporotic Patients.

Lost bone in osteoporotic patients increases the risk of fractures and back pain, and decreases quality of life. The aim of this study was to analyse the effect of teriparatide (TPTD) in osteoporotic ...

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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