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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Forteo Trial on Idiopathic Osteoporosis in Premenopausal Women

NCTNCT01440803 (opens ClinicalTrials.gov in a new tab)Other idAAAF2251Other idR01FD003902-01
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
41 participants (actual)
Sponsor
Elizabeth Shane · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
2 Aug 2012
Primary completion
1 Jan 2018
Completion
1 Feb 2019
First posted
27 Sept 2011 (estimated)
Last update posted
11 Dec 2019
Conditions
Adult Idiopathic Generalized Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20122014201620182020
  1. Ph 2

    Forteo Trial on Idiopathic Osteoporosis in Premenopausal Women

    NCT01440803

    2 Aug 2012 to 1 Feb 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • TeriparatideDrug
  • Saline PlaceboDrug

Arms2

  • Active comparator

    Teriparatide (Forteo)

    Daily injection of Teriparatide for treatment of idiopathic osteoporosis

  • Placebo comparator

    Placebo saline injection

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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Lumbar Spine Bone Mineral Density (LS-BMD) on Active Medication

    Time frame · Baseline and 12 months

    Registry description

    Dual Energy X-ray Absorptiometry (DXA) will be used to measuring bone mineral density (BMD).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Baseline and 12 months

Change in Lumbar Spine Bone Mineral Density (LS-BMD) on Active Medication

GroupValue (percentage of change)Spread
Teriparatide (Forteo)10.15.4
Placebo Saline Injection4.16.5

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Teriparatide (Forteo) (24 Months)Daily injection of 20 mcg teriparatide for the treatment of idiopathic osteoporosis for 24 months.0 / 280 / 280 / 28
Placebo Saline Injection (6 Months)Daily injection of saline placebo for 6 months.0 / 130 / 130 / 13
Placebo Saline Injection (6-24 Months)Daily injection of 20 mcg teriparatide for the treatment of idiopathic osteoporosis for 18 months following placebo.0 / 130 / 130 / 13

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2020

10 results

Effect of Teriparatide on Bone Remodeling and Density in Premenopausal Idiopathic Osteoporosis: A Phase II Trial.

Cohen et al. 2020The Journal of clinical endocrinology and metabolismcited by 30

PMID 32876328PMC8921657DOI 10.1210/clinem/dgaa489PUB-32876328

Rights unknown10 results
Source linkSee results (10)

Indexing hint: Clinical trial · 2013

17 results

Teriparatide for idiopathic osteoporosis in premenopausal women: a pilot study.

Cohen et al. 2013The Journal of clinical endocrinology and metabolismcited by 69

PMID 23543660PMC3644608DOI 10.1210/jc.2013-1172PUB-23543660

Rights unknown17 results
Source linkSee results (17)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedCohen A, Kamanda-Kosseh M, Recker RR, Lappe JM, Dempster DW, Zhou H, Cremers S, Bucovsky M, Stubby J, Shane E. Bone Density After Teriparatide Discontinuation in Premenopausal Idiopathic Osteoporosis. J Clin Endocrinol Metab. 2015 Nov;100(11):4208-14. doi: 10.1210/jc.2015-2829. Epub 2015 Sep 10. PMID 26358172
  • DerivedNishiyama KK, Cohen A, Young P, Wang J, Lappe JM, Guo XE, Dempster DW, Recker RR, Shane E. Teriparatide increases strength of the peripheral skeleton in premenopausal women with idiopathic osteoporosis: a pilot HR-pQCT study. J Clin Endocrinol Metab. 2014 Jul;99(7):2418-25. doi: 10.1210/jc.2014-1041. Epub 2014 Mar 31. PMID 24684466

Eligibility

Who could join, as posted.

Sex
Female
Age
from 20 Years up to 45 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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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