Skip to content

Trial · Interventional

CompletedPhase 2/3Results postedRegistry data

Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women

Short name IOPForteo

Overview

Status
Completed
Phase
Phase 2/3
Enrollment
22 participants (actual)
Sponsor
Columbia University · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
20 Aug 2008
Primary completion
3 Jan 2012
Completion
3 Jan 2012
First posted
13 Jun 2008 (estimated)
Last update posted
26 Jul 2018
Conditions
Menopause · Fracture · Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200820092010201120122013
  1. Ph 2/3

    IOPForteo

    NCT00697463

    20 Aug 2008 to 3 Jan 2012

Registry summary

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

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.

Interventions

  • Teriparatide (PTH 1-34)Drug

Arms1

  • Experimental

    Women with Idiopathic osteoporosis (IOP)

    Each subject will receive 20 micrograms of Teriparatide (PTH 1-34) subcutaneously daily for 18 -24 months

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Lumbar Spine Bone Density by Dual Energy X-ray Absorptiometry (DXA)

    Time frame · Baseline, Month 18 or 24 reported

    Registry description

    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.

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, Month 18 or 24 reported

Change in Lumbar Spine Bone Density by Dual Energy X-ray Absorptiometry (DXA)

GroupValue (percentage of BMD change)Spread
Women With Idiopathic Osteoporosis (IOP)10.88.3

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Women With Idiopathic Osteoporosis (IOP)Each subject will receive 20 micrograms of teriparatide subcutaneously daily. Teriparatide (PTH 1-34): 20 micrograms subcutaneous injection daily for 18-24 months0 / 210 / 218 / 21

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

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 20 Years up to 48 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Premenopausal women of all races. * Ages 20 to 48. * Regular menses (at least 8 periods in the last 12 months). * FSH \< 20 mIU/ml during the early follicular phase, to exclude women in the perimenopause. * Fracture subjects: documented low trauma fracture(s) at age \>= 18 (e.g., fracture associated with a fall from a standing height or less). * Low BMD subjects: DXA BMD T score less than or equal to 2.5 at the LS, total hip, femoral neck or distal radius, who have not had a fracture. * Control subjects: DXA BMD T score greater than or equal to 1.0 at the LS, total hip, femoral neck and distal radius, who have not had a fracture. * All subjects must use appropriate birth control methods to prevent pregnancy for the duration of teriparatide treatment. Exclusion Criteria: * Secondary Causes of Osteoporosis. * Disorders of mineral metabolism: primary or secondary hyperparathyroidism (serum intact PTH \> 65 pg/ml), vitamin D deficiency (serum 25OHD \< 30 ng/ml), hypercalciuria (\>300 mg/g creatinine), Paget's disease, clinical osteomalacia, osteogenesis imperfecta (OI). * Recent pregnancy or lactation (within past year). * Prolonged amenorrhea (\> 6 months) during reproductive years (except during pregnancy or lactation). * History of anorexia nervosa. * Malignancy, except cured basal or squamous cell skin carcinoma. * Endocrinopathy: hyperthyroidism (elevated serum thyroxine and/or suppressed TSH), untreated hypothyroidism, Cushing's syndrome, prolactin-secreting pituitary adenoma. * Renal insufficiency (serum creatinine above upper limit of female normal range). * Liver disease (AST, ALT, bilirubin, total alkaline phosphatase activity above upper normal limit). * Intestinal disorders (celiac disease, pancreatic insufficiency, inflammatory bowel disease). * History or current use of glucocorticoids, anticonvulsants, anticoagulants, diuretics, methotrexate. * Current use of depot preparations of progesterone or GnRH agonists. * Current use of drug therapies for osteoporosis (estrogen preparations other than contraceptives, raloxifene, bisphosphonates, calcitonin, PTH). Subjects who agree to discontinue use of these medications will be eligible to participate 6 months after discontinuing raloxifene or calcitonin, and 12 months after discontinuing bisphosphonates. Total exposure to bisphosphonates must be \< 1 year. Subjects who have taken PTH at any time in the past will not be eligible. * Additional contraindications to teriparatide use: Unexplained elevated total or bone specific alkaline phosphatase or prior external beam or implant radiation therapy involving the skeleton.

PepBank is a research reference. Talk to a doctor before you use any peptide.