Trial record 16 of 969 for:    "Osteoporosis"

Comparison Study of PTHrP and PTH to Treat Osteoporosis

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Mara Horwitz, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00853723
First received: February 27, 2009
Last updated: April 25, 2014
Last verified: April 2014
  Purpose

This is a three month comparison trial of standard dose parathyroid Hormone (PTH (1-34) and two different doses of Parathyroid Hormone-related Protein (PTHrP). The investigators want to to demonstrate that daily subcutaneous injection of PTHrP (1-36) in postmenopausal women with osteoporosis stimulates bone formation to the same or greater degree than PTH (1-34) but with less bone resorption.


Condition Intervention Phase
Osteoporosis
Drug: Parathyroid hormone related protein (1-36)
Drug: Parathyroid hormone related protein(1-36)
Drug: Parathyroid hormone (1-34)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of 3 Month PTHrP(1-36) and PTH(1-34) on Post-Menopausal Osteoporosis

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Comparison of PTHrP groups with PTH group on procollagen-1 amino-terminal peptide (P1NP)and plasma carboxy-terminal peptide of procollagen-1 (CTX)measurements after 3 months of treatment relative to baseline. [ Time Frame: At study completion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in bone mineral density of the lumbar spine, hip, and wrist in subjects receiving both PTH and PTHrP. [ Time Frame: At study completion ] [ Designated as safety issue: No ]
  • Demonstration of safety parameters of three months of PTHrP treatment. [ Time Frame: At study completion ] [ Designated as safety issue: Yes ]
  • Evaluation of changes in other markers of bone metabolism in subjects receiving both PTH and PTHrP. [ Time Frame: At study completion ] [ Designated as safety issue: No ]

Enrollment: 377
Study Start Date: May 2009
Study Completion Date: June 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PTHrP 400 mcg/day
Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
Drug: Parathyroid hormone related protein (1-36)
PTHrP (1-36) 400 micrograms / day administered subcutaneously for 3 months
Other Names:
  • PTHrP (1-36)
  • PTHrP
Experimental: PTHrP 600 mcg/day
Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
Drug: Parathyroid hormone related protein(1-36)
PTHrP(1-36)600 micrograms subcutaneously administered daily for 3 months
Other Names:
  • PTHrP (1-36)
  • PTHrP
Active Comparator: PTH 20 mcg/day
Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
Drug: Parathyroid hormone (1-34)
PTH(1-34)20 micrograms subcutaneously administered daily for 3 months
Other Names:
  • Parathyroid hormone (1-34)
  • PTH(1-34)
  • Teriparatide (brand name: Forteo)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 45 - 75 year old Caucasian, Hispanic or Asian women
  • one year post-menopausal if older than 50 years
  • three years post-menopausal if between the ages of 45 - 50 years
  • body mass index less than or equal to 30
  • T-scores on screening Dual X-Ray Absorbiometry (DXA) scan between - 2.0 to - 4.5 of lumbar spine or hip
  • have at lease two spinal vertebrae evaluable by DXA analysis

Exclusion Criteria:

  • bisphosphonate therapy within the last two years
  • estrogen replacement hormones or SERMS within last one year
  • no more than one week of PTHrP, PTH, or an analog of PTH within the last year
  • an atraumatic bone fracture within the last 6 months
  • significant or active diseases of any organ system
  • history of malignancy
  • anemia with a hematocrit less than 34%
  • significant drug or alcohol abuse
  • having received any investigational drug within the last 90 days
  • taking any medication that may interfere with skeletal metabolism, such as phenobarbital, dilantin, glucocorticoids, and hydrochlorathiazide
  • abnormal screening labs including serum Ca greater than 10.5 g/dl, 25 hydroxy vitamin D less than 20 ng/ml or PTH greater than 65 pg/ml
  • African-Americans for this particular study - although future studies are planned
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00853723

Locations
United States, Pennsylvania
UPMC Clinical & Translational Research Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Mara J Horwitz, MD University of Pittsburgh
  More Information

Publications:
Horwitz MJ, Stewart Af. Humoral hypercalcemia of malignancy. In: Favus MF (ed.) Primer on Metabolic Bone Diseases and Disorders of Mineral Metabolism, 5th ed. American Society for Bone and Mineral Research, Washington, DC, USA, pp. 246-250:2003.

Responsible Party: Mara Horwitz, Associate Professor, University of Pittsburgh School of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00853723     History of Changes
Other Study ID Numbers: PRO08100148, R01DK051081
Study First Received: February 27, 2009
Last Updated: April 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
osteoporosis
post-menopausal
bone anabolic agents

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

ClinicalTrials.gov processed this record on July 28, 2014