Comparison Study of PTHrP and PTH to Treat Osteoporosis

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Mara Horwitz, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00853723
First received: February 27, 2009
Last updated: February 24, 2016
Last verified: February 2016
  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) (1-36). 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:
  • Procallagen-1 Amino-terminal Peptide (P1NP) [ Time Frame: Baseline, Day 15, Day 30, Day 60, Day 90 ] [ Designated as safety issue: No ]
  • Carboxy-terminal Telopeptides of Collagen-1 (CTX) [ Time Frame: Baseline, Day 15, Day 30, Day 60, Day 90 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in Bone Mineral Density of the Lumbar Spine. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Changes in Bone Mineral Density of the Total Hip. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Changes in Bone Mineral Density of the Femoral Neck. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Changes in Bone Mineral Density of the Forearm. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Changes in Bone Mineral Density of the Distal 1/3 Radius. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • Total Serum Calcium (mg/dl) [ Time Frame: Baseline, Day 15, Day 30, Day 60, Day 90 ] [ Designated as safety issue: Yes ]
  • Serum Phosphorous [ Time Frame: Baseline, Day 15, Day 30, Day 60, Day 90 ] [ Designated as safety issue: Yes ]
  • 24 Hour Urine Calcium [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • 1,25 Vitamin D [ Time Frame: Baseline, Day 15, Day 30, Day 60, Day 90 ] [ Designated as safety issue: No ]
  • Fractional Excretion of Calcium [ Time Frame: Baseline, Day 15, Day 30, Day 60, Day 90 ] [ Designated as safety issue: No ]
    (Serum Creatinine X Urine Calcium)/(Serum Calcium X Urine Creatinine)

  • Tubular Maximum for Phosphorous/Glomerular Filtration Rate (TMP/GFR) [ Time Frame: Baseline, Day 15, Day 30, Day 60, Day 90 ] [ Designated as safety issue: No ]

    Fractional tubular reabsorption of phosphate (TRP) = 1-{(U phos/P phos) x ( P creat/U creat)} if TRP < or = 0.86 then TMP/GFR = TRP x P phos if TRP > 0.86 then TMP/GFR = 0.3 x TRP/{1-(0.8 x TRP)} x P phos

    U= urine, P = plasma



Enrollment: 105
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:
  • PTH(1-34)
  • Teriparatide (brand name: Forteo)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
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
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: NCT00853723

Locations
United States, Pennsylvania
UPMC Clinical & Translational Research Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Mara J Horwitz, MD University of Pittsburgh
  More Information

Additional Information:
Publications:
http://www.nof.org/osteoporosis/diseasefacts.htm. Accessed August 22, 2008
FORTEO (package insert). Indianapolis, IN: Eli Lilly and Company; 2008.
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
Results First Received: July 15, 2015
Last Updated: February 24, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

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

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

ClinicalTrials.gov processed this record on August 24, 2016