Forteo Trial on Idiopathic Osteoporosis in Premenopausal Women

Summary

Idiopathic osteoporosis (IOP) is defined as osteoporosis that affects young, otherwise completely healthy individuals with no secondary cause of bone loss. In the course of our prior research with premenopausal women with IOP, the investigators have shown that women with IOP have low areal bone mineral density (aBMD) at the spine, hip and forearm compared to normal women. Additionally, using noninvasive high resolution imaging of the central and peripheral skeleton and detailed analyses of transiliac crest bone biopsies, the investigators identified several features of bone quality in premenopausal women with IOP.

There is currently no FDA-approved therapy for IOP in premenopausal women. However, teriparatide (Forteo) has been shown to improve bone mass and microarchitecture in postmenopausal women and is approved for men with primary or idiopathic osteoporosis, as well as men, premenopausal and postmenopausal women with glucocorticoid-induced osteoporosis. Because IOP in premenopausal women is an orphan disease, with an estimated prevalence of about 113,000 in the United States, pharmaceutical companies are unlikely to support development of therapies for this indication. Therefore, the major objective of this protocol is to establish the safety and efficacy of teriparatide in premenopausal women with IOP in a phase 2 clinical trial. All subjects will receive teriparatide as part of the study, but a randomly selected group of patients (10) will receive one year of placebo injections first before starting their two years of treatment. The remainder of subjects (30) will receive active drug only for two years.

Funding Source - FDA OOPD

Conditions

• Adult Idiopathic Generalized Osteoporosis

Interventions

DRUG

Teriparatide

Daily injection of 20 mcg teriparatide for the treatment of idiopathic osteoporosis for 24 months.

DRUG

Saline Placebo

Daily injection of saline placebo for 6 months, followed by teriparatide treatment for 24 months.

Sponsors & Collaborators

• Food and Drug Administration (FDA)

  collaborator FED

• Elizabeth Shane

  lead OTHER

Principal Investigators

• Elizabeth Shane, MD · Columbia University

• Adi Cohen, MD · Columbia University

• Emily M Stein, MD · Columbia University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

20 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-08-02

Primary Completion

2018-01-01

Completion

2019-02-01

FDA Drug

Yes

Countries

• United States

Study Locations