NCT00697463: IOPForteo

Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women

Completed Phase 2, PHASE3 Results posted Last updated 26 July 2018

What this trial tests

Phase 2, PHASE3 trial testing Teriparatide (PTH 1-34) in Menopause in 22 participants. Completed in 3 January 2012.

Timeline

20 August 2008

Primary endpoint
3 January 2012

3 January 2012

Quick facts

Lead sponsor	Columbia University
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	22
Start date	20 August 2008
Primary completion	3 January 2012
Estimated completion	3 January 2012
Sites	2 locations across United States

Drugs / interventions tested

• Teriparatide (PTH 1-34) — full drug profile →

Conditions studied

• Menopause — all drugs for Menopause →
• Fracture — all drugs for Fracture →
• Osteoporosis — all drugs for Osteoporosis →

Sponsor

Columbia University

Who can join

Adults 20 to 48, female only, with Menopause or Fracture. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Lumbar Spine Bone Density by Dual Energy X-ray Absorptiometry (DXA) Primary · Baseline, Month 18 or 24 reported

Areal BMD at the lumbar spine was measured by dual energy x-ray absorptiometry (DXA) at baseline and at 6, 12, 18, and 24 months, if possible.

Group	Value	95% CI
Women With Idiopathic Osteoporosis (IOP)	10.8	± 8.3

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were assessed through study completion.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Women With Idiopathic Osteoporosis (IOP)

Serious: 0/21 (0%)

Deaths: 0/21

Other adverse events (3 terms — click to expand)

Reaction	System	Women With Idiopathic Oste…
Hypercalciuria	Renal and urinary disorders	—
Hypercalcemia	Blood and lymphatic system disorders	—
Distal radius fracture	Musculoskeletal and connective tissue disorders	—

Data from ClinicalTrials.gov NCT00697463 adverse events section.

Sponsor's own description

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. The investigators hypothesize that teriparatide will significantly increase bone density (BMD) and improve bone structure in premenopausal women with IOP.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.