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Trial record 24 of 841 for:    osteoporosis AND (woman OR women OR female)

Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women (IOPForteo)

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ClinicalTrials.gov Identifier: NCT00697463
Recruitment Status : Completed
First Posted : June 13, 2008
Results First Posted : July 26, 2018
Last Update Posted : July 26, 2018
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Elizabeth Shane, Columbia University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Menopause Fracture Osteoporosis Drug: Teriparatide (PTH 1-34) Phase 2 Phase 3

Detailed Description:

Idiopathic osteoporosis (IOP) is an uncommon disorder in which otherwise healthy young individuals sustain one or more low-trauma fractures. In studies of IOP in men, histomorphometric indices of bone formation are depressed, and affected men respond to PTH(1-34) with robust increases in lumbar spine (LS) bone mineral density (BMD). This is the beginning of the third year of an R01 (AR4989603) investigating the etiology and pathogenesis, as well as the histomorphometric and bone microarchitectural features of IOP in premenopausal women. There is evidence of markedly decreased bone formation and microarchitectural deterioration with decreased mechanical competence/strength.

Teriparatide [PTH(1-34)] is an anabolic agent that stimulates bone formation and improves bone microarchitecture. Based on findings, the investigators hypothesize that teriparatide will significantly increase BMD and improve microarchitecture in premenopausal women with IOP.

This is an open-label study of carefully characterized premenopausal women with IOP who are participating in a NIH-funded study and who have fragility fractures or very low bone density. Participants in the study will receive 18-24 months of teriparatide and the effects on BMD and microstructure, bone mechanical competence, and bone turnover will be assessed. In order to assess whether teriparatide stimulates bone formation to the same extent in women with IOP as it does in normal women, the study will compare the short-term changes (2 and 4 weeks) in biochemical markers of bone formation in response to teriparatide between women with IOP and normal women who are participating in another NIH-funded study as controls.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Teriparatide for the Treatment of Idiopathic Osteoporosis in Premenopausal Women
Actual Study Start Date : August 20, 2008
Actual Primary Completion Date : January 3, 2012
Actual Study Completion Date : January 3, 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Women with Idiopathic osteoporosis (IOP)
Each subject will receive 20 micrograms of Teriparatide (PTH 1-34) subcutaneously daily for 18 -24 months
Drug: Teriparatide (PTH 1-34)
20 micrograms subcutaneous injection daily
Other Name: Forteo




Primary Outcome Measures :
  1. Change in Lumbar Spine Bone Density by Dual Energy X-ray Absorptiometry (DXA) [ Time Frame: 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.



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Ages Eligible for Study:   20 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00697463


Locations
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
Columbia University
Eli Lilly and Company
Investigators
Principal Investigator: Elizabeth Shane, MD Columbia University
Study Director: Adi Cohen, MD Columbia University

Responsible Party: Elizabeth Shane, Professor of Medicine, Endocrinology, Columbia University
ClinicalTrials.gov Identifier: NCT00697463     History of Changes
Other Study ID Numbers: AAAC6871
First Posted: June 13, 2008    Key Record Dates
Results First Posted: July 26, 2018
Last Update Posted: July 26, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Elizabeth Shane, Columbia University:
Teriparatide
Forteo
Osteopenia
Osteoporosis
Fracture
Low Bone Density
Premenopausal women

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