Once Weekly Parathyroid Hormone for Osteoporosis

NCT00065637 | Completed Phase 3

• 3 other identifiers: N01 AR32268N01AR002245-000NIAMS-092
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Daily parathyroid hormone (PTH) is approved by the FDA for the treatment of osteoporosis. This study will evaluate the safety and effectiveness of PTH when given once a week.

Conditions

Osteopenia; Osteoporosis

Outcome Measures

Primary Outcomes (1)

• Bone mineral density

  Months 6 and 12

Study Arms (2)

1

EXPERIMENTAL

Women will self-administer PTH injections daily for 4 weeks, then once weekly for 48 weeks

Drug: Teriparatide

2

PLACEBO COMPARATOR

Women will self-administer placebo injections daily for 4 weeks, then once weekly for 48 weeks

Drug: Placebo teriparatide

Interventions

Teriparatide DRUG

Synthetic human parathyroid hormone

1

Placebo teriparatide DRUG

Placebo injections

2

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bone mineral density scan with a T-score between -1 and -2
• Willing to self-administer injections
• Postmenopausal

You may not qualify if:

• Medications to treat osteoporosis, including: hormone replacement therapy for more than one month in the 6 months prior to study, or for more than 12 months in the 2 years prior to study; alendronate, risedronate, or etidronate for more than 1 year anytime prior to study; calcitonin in the 3 months prior to study; taken raloxifene or tamoxifen in the last 6 months or for more than 1 year in the 2 years prior to study; fluoride for more than 1 month in the 5 years prior to study
• Bone fracture since menopause
• Femoral neck T-score below -2 AND lumbar spine T-score below -2.5 OR femoral neck T-score below -2.5 AND T-scores of both total hip and lumbar spine below -2

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

St Joseph Hospital

Bangor, Maine, 04401, United States

Location

Related Publications (2)

• Brown SA, Rosen CJ. Osteoporosis. Med Clin North Am. 2003 Sep;87(5):1039-63. doi: 10.1016/s0025-7125(03)00065-8.

  PMID: 14621330 BACKGROUND

• Rosen CJ. The cellular and clinical parameters of anabolic therapy for osteoporosis. Crit Rev Eukaryot Gene Expr. 2003;13(1):25-38. doi: 10.1615/critreveukaryotgeneexpr.v13.i1.30.

  PMID: 12839095 BACKGROUND

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Clifford Rosen, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2003
• First Posted: July 30, 2003
• Study Start: December 1, 2003
• Primary Completion: September 1, 2005
• Study Completion: September 1, 2005
• Last Updated: February 5, 2013

Record last verified: 2013-02

Locations

US (1)