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Forteo Trial on Idiopathic Osteoporosis in Premenopausal Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Columbia University
Sponsor:
Collaborator:
Creighton University
Information provided by (Responsible Party):
Elizabeth Shane, Columbia University
ClinicalTrials.gov Identifier:
NCT01440803
First received: September 23, 2011
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

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 FDAapproved 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.


Condition Intervention Phase
Adult Idiopathic Generalized Osteoporosis
Drug: Teriparatide
Drug: Saline Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Teriparatide for the Treatment of Idiopathic Osteoporosis in Premenopausal Women

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Change in lumbar spine bone mineral density (LS-BMD) [ Time Frame: Baseline and 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Teriparatide (Forteo)
Daily injection of Teriparatide for treatment of idiopathic osteoporosis
Drug: Teriparatide
Daily injection of 20 mcg teriparatide for the treatment of idiopathic osteoporosis for 24 months.
Other Name: Forteo
Placebo Comparator: Placebo saline injection
Daily injection of saline placebo for 6 months, followed by 24 months of teriparatide treatment for idiopathic osteoporosis.
Drug: Saline Placebo
Daily injection of saline placebo for 6 months, followed by teriparatide treatment for 24 months.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Premenopausal women, aged 20-45, with regular menses and no historical or biochemical secondary cause of osteoporosis.
  • Documented adult fractures judged to be low-trauma.
  • Must be willing to use effective contraception throughout the period of study drug administration.

Inclusion criteria vary slightly based on age category:

  • Premenopausal women ages 20-35 years must have at least one major osteoporotic fracture (excluding fractures of fingers, toes and face) AND low Bone Mineral Density(BMD).
  • Premenopausal women above the age of 35 years should have a history of fracture AND/OR low BMD.

Exclusion Criteria:

  • History of any condition that increases the risk of osteosarcoma
  • Early follicular phase serum
  • Disorders of mineral metabolism
  • Suspicion of osteomalacia
  • Vitamin D deficiency
  • Pregnancy or lactation within past 12 months
  • Prolonged amenorrhea (> 6 months) during reproductive years (except pregnancy or lactation)
  • Prior eating disorder
  • Malignancy, except cured basal or squamous cell skin carcinoma
  • Endocrinopathy: new onset untreated hyperthyroidism, hypothyroidism, Cushing's syndrome, prolactinoma
  • Renal insufficiency
  • Liver disease
  • Intestinal disorders
  • History/current GCs, anticonvulsants, anticoagulants, methotrexate, depot progesterone, GnRH agonists
  • Oral glucocorticoid use (subject will not be excluded if used dose equivalent to less than prednisone 5 mg for <3 months).
  • Current anticoagulant use or low molecular weight
  • Depo Provera use (subjects will not be excluded if used at age>20, >5 years ago)
  • Drugs for osteoporosis (raloxifene, bisphosphonates, denosumab, calcitonin, TPTD). Subjects who discontinue these medications will be eligible 3 months after stopping raloxifene or calcitonin, 12 months after stopping alendronate, risedronate, ibandronate, or pamidronate and 18 months after stopping denosumab. Subjects with prior use of zoledronate may be eligible if received only one dose >4 years ago. Total bisphosphonate exposure must be < 1 year. Subjects who have taken TPTD in the past will not be eligible unless used for <3 months, > 2 years ago.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01440803

Contacts
Contact: Mariana Bucovsky, BA 212-305-7225 mb3523@columbia.edu
Contact: Adi Cohen, MD 212-342-1291 ac1044@columbia.edu

Locations
United States, Nebraska
Creighton University Recruiting
Omaha, Nebraska, United States, 68131
Contact    402-280-4470      
Principal Investigator: Robert Recker, MD         
Sub-Investigator: Joan Lappe, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact    212-305-7225      
Principal Investigator: Elizabeth Shane, MD         
Sub-Investigator: Adi Cohen, MD         
Sub-Investigator: Emily M Stein, MD         
Sponsors and Collaborators
Elizabeth Shane
Creighton University
Investigators
Principal Investigator: Elizabeth Shane, MD Columbia University
Study Director: Adi Cohen, MD Columbia University
Study Director: Emily M Stein, MD Columbia University
  More Information

Additional Information:
No publications provided by Columbia University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Elizabeth Shane, Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT01440803     History of Changes
Other Study ID Numbers: AAAF2251, R01FD003902-01
Study First Received: September 23, 2011
Last Updated: August 20, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Columbia University:
osteoporosis
premenopausal
forteo
idiopathic
Idiopathic Osteoporosis in Premenopausal Women

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Teriparatide
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 19, 2014