PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dennis Black, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00005005
First received: March 24, 2000
Last updated: February 4, 2013
Last verified: February 2013
  Purpose

This 2-year study will test the effectiveness of combining parathyroid hormone (PTH) and alendronate for treating osteoporosis in postmenopausal women. Alendronate is a drug used to treat osteoporosis and primarily prevents bone loss, whereas PTH increases bone formation. We will treat the study participants either with PTH and alendronate, alendronate alone, or PTH alone. We will determine the effects of these treatments by looking for changes in bone mineral density in the hip and spine.


Condition Intervention Phase
Osteoporosis
Drug: PTH
Drug: Alendronate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Clinical Trial of Parathyroid Hormone (PTH) and Alendronate in Combination in the Treatment of Osteoporosis

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Changes in bone mineral density at several sites and changes in biochemical markers [ Time Frame: Year 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Predictive value of specific biochemical markers of bone turnover [ Time Frame: Year 2 ] [ Designated as safety issue: No ]

Enrollment: 238
Study Start Date: October 1999
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive PTH for 1 year followed by alendronate for 1 year.
Drug: PTH Drug: Alendronate
Experimental: 2
Participants will receive PTH and alendronate for 1 year followed by alendronate for 1 year.
Drug: PTH Drug: Alendronate
Experimental: 3
Participants will receive alendronate for 2 years.
Drug: Alendronate
Active Comparator: 4
Participants will receive PTH for 1 year followed by placebo for 1 year.
Drug: PTH

Detailed Description:

The PaTH study is a 2-year, multicenter, double-blind, placebo-controlled trial to test the efficacy of combining hPTH (1-84) and alendronate for treating osteoporosis in postmenopausal women.

238 women were randomized between 55 and 85 years of age to receive either: (1) PTH for 1 year followed by alendronate for 1 year; (2) PTH and alendronate for 1 year followed by alendronate for 1 year; (3) alendronate for 2 years; or (4) PTH for 1 year followed by placebo for 1 year. The primary endpoints are changes in bone mineral density at several sites and changes in biochemical markers.

In addition, we will assess specific biochemical markers of bone turnover (e.g., osteocalcin, deoxypridinoline, N-telopeptide, bone-specific alkaline phosphatase and bone sialoprotein) to determine if they can predict the skeletal response to combination therapy. We will also determine whether PTH positively affects ultrasound measurements in the calcaneus.

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged between 55 and 85 years
  • Postmenopausal (have not had any menses in the last 5 years)
  • Have a bone mineral density scan (DXA) that can be evaluated at the spine AND at the hip with a T-score equal to or below -2.5 at the spine or the femoral neck or total hip OR T-score equal to or below -2.0 at the spine or the femoral neck or total hip and have at least one of the following risk factors for fracture: (a) age > 65 years; (b) history of postmenopausal fracture (nonvertebral or vertebral); or (c) maternal history of hip fracture
  • Willing and able to self-administer daily injections

Exclusion Criteria:

  • Have used estrogen (oral or patch) for more than 1 month in the last 6 months or more than 12 months in the last 2 years
  • History of more than 12 months of bisphosphonate use ever, or any use (> 4 weeks) within the past 12 months
  • History of rhPTH (recombinant human PTH) use
  • Any major life-threatening illnesses
  • Type 1 or uncontrolled type 2 diabetes mellitus (defined as hemoglobin A1C > 10.0), or currently using insulin
  • Vitamin D level < 15 nanograms/ml
  • History of kidney disease (creatinine > 2.0 mg/dl)
  • Renal insufficiency (creatinine clearance < 40 mg/min)
  • Any history of kidney stones
  • Any history of hypercalciuria or currently have urine calcium/creatinine >300 mg
  • History of hypercalcemia, sarcoidosis, or hyperparathyroidism
  • History of active or treated tuberculosis or other granulomatous disorders
  • History of breast cancer, melanoma, or hematologic malignancy that has required treatment within the last 10 years
  • History of bone cancer or any other metabolic bone disease that has required treatment within the last 10 years
  • History of any other nonskin cancer that has required treatment within the last 10 years
  • History of symptomatic esophageal reflux, achalasia or esophageal stricture
  • Currently taking > 7.5 mg systemic prednisone or equivalent per day
  • Currently using > two puffs, four times/day of inhaled steroids
  • Currently taking anticoagulants or anticonvulsants
  • Have used Calcitonin within the past 3 months
  • Have used Raloxifene in the last 6 months or for more than 12 months in the last 2 years
  • Have used Tamoxifen in the last 6 months or for more than 12 months in the last 2 years
  • Have used fluoride for at least a month within the past 5 years
  • Currently taking > 1000 IU/day vitamin D or vitamin D analogues or metabolites
  • Currently taking thyroid hormone replacement AND have a TSH < 0.1mIU/L
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005005

Locations
United States, Maine
Maine Center for Osteoporosis
Bangor, Maine, United States, 04401
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55415
United States, New York
Columbia University
New York, New York, United States, 10032
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Dennis Black
Investigators
Principal Investigator: Dennis Black, PhD University of California, San Francisco
  More Information

Publications:
Responsible Party: Dennis Black, Prinicipal Investigator, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00005005     History of Changes
Other Study ID Numbers: N01 AR92245, N01AR002245-000, NIAMS-045
Study First Received: March 24, 2000
Last Updated: February 4, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
PTH
Alendronate
Parathyroid hormone
Osteoporosis
Postmenopausal

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Alendronate
Hormones
Bone Density Conservation Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014