Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women

2014-08-27 03:29:54 | BioPortfolio


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.


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




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


Columbia University Medical Center
New York
New York
United States




Columbia University

Results (where available)

View Results


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

Clinical Trials [59 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 [22 Associated PubMed Articles listed on BioPortfolio]

Teriparatide Administration Increases Periprosthetic Bone Mineral Density After Total Knee Arthroplasty: A Prospective Study.

Teriparatide is a currently available therapeutic agent for osteoporosis. Previous studies have reported that teriparatide affects periprosthetic bone mineral density (BMD) after total knee arthroplas...

Population Pharmacokinetic and Exposure-Response Analysis of Weekly Teriparatide in Osteoporosis Patients.

Teriparatide is a potent therapeutic agent for the treatment of osteoporosis. One of the aims of this analysis was to develop a population pharmacokinetic (PPK) model to understand the pharmacokinetic...

Retrospective radiological outcome analysis following teriparatide use in elderly patients undergoing multilevel instrumented lumbar fusion surgery.

Elderly patients with chronic nonresolving symptoms due to degenerative spine pathologies are prone to have poor surgical outcomes and hardware-related complications, especially following multilevel i...

Efficacy of Teriparatide in Patients with Hypoparathyroidism: A Prospective, Open-label Study.

Conventional treatment of hypoparathyroidism with calcium, Vitamin D analogs, and thiazide diuretics is often suboptimal, and these patients have poor quality of life. Teriparatide (parathyroid hormon...

Acute development of cortical porosity and endosteal naïve bone formation from the daily but not weekly short-term administration of PTH in rabbit.

Teriparatide [human parathyroid hormone (1-34)], which exerts an anabolic effect on bone, is used for the treatment of osteoporosis in patients who are at a high risk for fracture. That the once-daily...

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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