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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis; Osteopenia
• Intervention / Treatment: Drug: Teriparatide; Drug: Placebo teriparatide

Detailed Description

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.

• Study Type: Interventional
• Enrollment: 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Maine
    • Bangor, Maine, United States, 04401
      • St Joseph Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Women will self-administer PTH injections daily for 4 weeks, then once weekly for 48 weeks	Drug: Teriparatide; Synthetic human parathyroid hormone
Placebo Comparator: 2; Women will self-administer placebo injections daily for 4 weeks, then once weekly for 48 weeks	Drug: Placebo teriparatide; Placebo injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bone mineral density	Months 6 and 12

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Clifford Rosen, MD, Unity Health Toronto

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: December 1, 2003
• Primary Completion (Actual): September 1, 2005
• Study Completion (Actual): September 1, 2005

Study Registration Dates

• First Submitted: July 29, 2003
• First Submitted That Met QC Criteria: July 29, 2003
• First Posted (Estimate): July 30, 2003

Study Record Updates

• Last Update Posted (Estimate): February 5, 2013
• Last Update Submitted That Met QC Criteria: February 4, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Osteoporosis; Bone Diseases, Metabolic; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Teriparatide
• Other Study ID Numbers: N01 AR32268; N01AR002245-000 (U.S. NIH Grant/Contract); NIAMS-092