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Once Weekly Parathyroid Hormone for Osteoporosis

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00065637
First received: July 29, 2003
Last updated: February 4, 2013
Last verified: February 2013

July 29, 2003
February 4, 2013
December 2003
September 2005   (final data collection date for primary outcome measure)
Bone mineral density [ Time Frame: Months 6 and 12 ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00065637 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Once Weekly Parathyroid Hormone for Osteoporosis
PTH Once Weekly Research (POWR)

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.

In osteoporosis, skeletal bone mass and strength are so reduced that fractures occur after only modest levels of mechanical stress that would not harm normal bone. Fractures of the hip, spine, and wrists are most typical, though fractures of the ribs, pelvis, and humerus also occur. Research has shown that hip fractures cause a 10% to 20% increase in mortality, and the cost of all osteoporotic fractures is estimated to be $6.14 billion in health care costs and lost earnings per year. The most common form of osteoporosis is postmenopausal osteoporosis. A reduction in bone mineral density of approximately 1% to 2% per year is observed for the first 3 to 5 years after the onset of menopause, then 0.5% to 1% per year thereafter.

PTH was recently approved by the FDA as a daily treatment for osteoporosis. However, PTH must be self-injected, is very expensive, and has been associated with worrisome side effects. The currently approved formulation of daily PTH self-injections is practical for only a small proportion of people with osteoporosis. A once weekly formulation could significantly decrease cost, difficulty of administration, and risks and side effects associated with daily use of PTH. A once weekly injection by a caregiver would also make PTH accessible to populations for whom daily self-injection may not be practical, such as the very elderly or those in assisted living or nursing homes. This study will evaluate the safety and effectiveness of once weekly PTH dosing for women with osteoporosis.

Women will be randomized to receive either PTH or placebo. Women will self-administer injections daily for 4 weeks, then once weekly for 48 weeks. All women will receive calcium and vitamin D supplements daily. Women will visit the clinic six times over the course of a year and will provide urine and blood samples at each visit. Bone mineral density will be measured at 6 and 12 months.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Osteopenia
  • Osteoporosis
  • Drug: Teriparatide
    Synthetic human parathyroid hormone
  • Drug: Placebo teriparatide
    Placebo injections
  • Experimental: 1
    Women will self-administer PTH injections daily for 4 weeks, then once weekly for 48 weeks
    Intervention: Drug: Teriparatide
  • Placebo Comparator: 2
    Women will self-administer placebo injections daily for 4 weeks, then once weekly for 48 weeks
    Intervention: Drug: Placebo teriparatide

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 2005
September 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Female
45 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00065637
N01 AR32268, N01AR002245-000, NIAMS-092
Not Provided
University of California, San Francisco
University of California, San Francisco
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Clifford Rosen, MD St. Joseph Hospital Health Center
University of California, San Francisco
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP