Forteo for the Treatment of Unexplained Osteoporosis in Premenopausal Women

NCT00697463 | Completed Phase 2 Results FDA Drug

• 1 other identifier: AAAC6871
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Menopause; Fracture; Osteoporosis

Keywords

Teriparatide; Forteo; Osteopenia; Osteoporosis; Fracture; Low Bone Density; Premenopausal women

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline, Month 18 or 24 reported

Study Arms (1)

Women with Idiopathic osteoporosis (IOP)

EXPERIMENTAL

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

Drug: Teriparatide (PTH 1-34)

Interventions

Teriparatide (PTH 1-34) DRUG

20 micrograms subcutaneous injection daily

Also known as: Forteo

Women with Idiopathic osteoporosis (IOP)

Eligibility Criteria

• Age: 20 Years - 48 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• Eli Lilly and Company: collaborator

Study Sites (2)

Creighton University

Omaha, Nebraska, 68131, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Fractures, Bone; Osteoporosis; Bone Diseases, Metabolic

Interventions

Teriparatide; Parathyroid Hormone

Condition Hierarchy (Ancestors)

Wounds and Injuries; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Without an untreated control group, we cannot attribute the observed effects to teriparatide with certainty. The effects of teriparatide on fractures could not be evaluated. Six women received teriparatide for 18 months rather than for 24 months.

Results Point of Contact

• Title: Elizabeth Shane, MD
• Organization: Columbia University

es54@cumc.columbia.edu

212-305-7225

Study Officials

• Elizabeth Shane, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Adi Cohen, MD

  Columbia University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Endocrinology

Study Record Dates

• First Submitted: June 11, 2008
• First Posted: June 13, 2008
• Study Start: August 20, 2008
• Primary Completion: January 3, 2012
• Study Completion: January 3, 2012
• Last Updated: July 26, 2018
• Results First Posted: July 26, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)