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Comparison Study of PTHrP and PTH to Treat Osteoporosis
This study has been completed.
Sponsor:
University of Pittsburgh
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
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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 Intervention Model: Factorial Assignment Masking: Single Blind (Participant) 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 Mara Horwitz, University of Pittsburgh:
Primary Outcome Measures:
- Procallagen-1 Amino-terminal Peptide (P1NP) [ Time Frame: Baseline, Day 15, Day 30, Day 60, Day 90 ]
- Carboxy-terminal Telopeptides of Collagen-1 (CTX) [ Time Frame: Baseline, Day 15, Day 30, Day 60, Day 90 ]
Secondary Outcome Measures:
- Changes in Bone Mineral Density of the Lumbar Spine. [ Time Frame: 90 days ]
- Changes in Bone Mineral Density of the Total Hip. [ Time Frame: 90 days ]
- Changes in Bone Mineral Density of the Femoral Neck. [ Time Frame: 90 days ]
- Changes in Bone Mineral Density of the Forearm. [ Time Frame: 90 days ]
- Changes in Bone Mineral Density of the Distal 1/3 Radius. [ Time Frame: 90 days ]
- Total Serum Calcium (mg/dl) [ Time Frame: Baseline, Day 15, Day 30, Day 60, Day 90 ]
- Serum Phosphorous [ Time Frame: Baseline, Day 15, Day 30, Day 60, Day 90 ]
- 24 Hour Urine Calcium [ Time Frame: 90 days ]
- 1,25 Vitamin D [ Time Frame: Baseline, Day 15, Day 30, Day 60, Day 90 ]
- 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)
- 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
| 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:
|
|
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:
|
|
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:
|
Show Detailed Description
Eligibility| 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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00853723
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 ( US NIH Grant/Contract Award Number ) |
| Study First Received: | February 27, 2009 |
| Results First Received: | July 15, 2015 |
| Last Updated: | February 24, 2016 |
| Individual Participant Data | |
| 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 Hormones |
Teriparatide Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents |
ClinicalTrials.gov processed this record on June 23, 2017