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Comparison Study of PTHrP and PTH to Treat Osteoporosis

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ClinicalTrials.gov Identifier: NCT00853723
Recruitment Status : Completed
First Posted : March 2, 2009
Results First Posted : February 24, 2016
Last Update Posted : March 24, 2016
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

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Osteoporosis Drug: Parathyroid hormone related protein (1-36) Drug: Parathyroid hormone related protein(1-36) Drug: Parathyroid hormone (1-34) Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of 3 Month PTHrP(1-36) and PTH(1-34) on Post-Menopausal Osteoporosis
Study Start Date : May 2009
Actual Primary Completion Date : February 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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)


Outcome Measures
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Primary Outcome Measures :
  1. Procallagen-1 Amino-terminal Peptide (P1NP) [ Time Frame: Baseline, Day 15, Day 30, Day 60, Day 90 ]
  2. Carboxy-terminal Telopeptides of Collagen-1 (CTX) [ Time Frame: Baseline, Day 15, Day 30, Day 60, Day 90 ]

Secondary Outcome Measures :
  1. Changes in Bone Mineral Density of the Lumbar Spine. [ Time Frame: 90 days ]
  2. Changes in Bone Mineral Density of the Total Hip. [ Time Frame: 90 days ]
  3. Changes in Bone Mineral Density of the Femoral Neck. [ Time Frame: 90 days ]
  4. Changes in Bone Mineral Density of the Forearm. [ Time Frame: 90 days ]
  5. Changes in Bone Mineral Density of the Distal 1/3 Radius. [ Time Frame: 90 days ]
  6. Total Serum Calcium (mg/dl) [ Time Frame: Baseline, Day 15, Day 30, Day 60, Day 90 ]
  7. Serum Phosphorous [ Time Frame: Baseline, Day 15, Day 30, Day 60, Day 90 ]
  8. 24 Hour Urine Calcium [ Time Frame: 90 days ]
  9. 1,25 Vitamin D [ Time Frame: Baseline, Day 15, Day 30, Day 60, Day 90 ]
  10. Fractional Excretion of Calcium [ Time Frame: Baseline, Day 15, Day 30, Day 60, Day 90 ]
    (Serum Creatinine X Urine Calcium)/(Serum Calcium X Urine Creatinine)

  11. Tubular Maximum for Phosphorous/Glomerular Filtration Rate (TMP/GFR) [ Time Frame: Baseline, Day 15, Day 30, Day 60, Day 90 ]

    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



Eligibility Criteria
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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes 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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
University of Pittsburgh's clinical research study website  This link exits the ClinicalTrials.gov site

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 ( U.S. NIH Grant/Contract )
First Posted: March 2, 2009    Key Record Dates
Results First Posted: February 24, 2016
Last Update Posted: March 24, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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