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Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women

2014-08-27 03:29:54 | 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

Published on BioPortfolio: 2014-08-27T03:29:54-0400

Clinical Trials [53 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 [20 Associated PubMed Articles listed on BioPortfolio]

Influences of teriparatide administration on marrow fat content in postmenopausal osteopenic women using MR spectroscopy.

Objective Teriparatide could induce osteoblast differentiation of mesenchymal stem cells while inhibiting adipocyte differentiation. However, there are significant differences between ex vivo and in v...

Eczematous dermatitis due to subcutaneous teriparatide injection.

Teriparatide, or recombinant human parathyroid hormone, is approved for the treatment of osteoporosis. Possible cutaneous adverse events of teriparatide are urticaria, injection site pain, swelling, b...

3. Can Combined Therapy With Teriparatide and Low-Intensity Pulsed Ultrasound (LIPUS) Accelerate Fracture Healing?

It is an advantage for orthopaedic surgeons to remove an Ilizarov external fixator as early as possible after surgery. Although both teriparatide and low-intensity pulsed ultrasound (LIPUS) have been ...

The Effect of Teriparatide on Fracture Healing of Osteoporotic Patients: A Meta-Analysis of Randomized Controlled Trials.

Purpose. This meta-analysis is to assess the effectiveness of teriparatide in fracture healing and clinical function improvement of the osteoporotic patients. Methods. We searched PubMed, Embase, Web ...

Trabecular Bone Score in Patients with Chronic Glucocorticoid-Induced Osteoporosis Treated with Alendronate or Teriparatide.

To determine the effect of alendronate (ALN) and teriparatide (TPTD) on trabecular bone score (TBS) in patients with glucocorticoid-induced osteoporosis (GIO).

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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