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Forteo Trial on Idiopathic Osteoporosis in Premenopausal Women

This study is ongoing, but not recruiting participants.
Creighton University
Information provided by (Responsible Party):
Elizabeth Shane, Columbia University Identifier:
First received: September 23, 2011
Last updated: December 16, 2016
Last verified: December 2016

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

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]

Enrollment: 41
Study Start Date: January 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2017 (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 Names:
  • Forteo
  • TPTD
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.
Other Name: Placebo

  Show Detailed Description


Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 glucocorticoids (GCs), anticonvulsants, anticoagulants, methotrexate, depot progesterone, Gonadotrophin-releasing hormone (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.
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Please refer to this study by its identifier: NCT01440803

United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68131
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Elizabeth Shane
Creighton University
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:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Elizabeth Shane, Professor of Medicine, Columbia University Identifier: NCT01440803     History of Changes
Other Study ID Numbers: AAAF2251
R01FD003902-01 ( US NIH Grant/Contract Award Number )
Study First Received: September 23, 2011
Last Updated: December 16, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Columbia University:
Idiopathic Osteoporosis in Premenopausal Women

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on April 25, 2017