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
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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 |

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 |

Arm | Intervention/treatment |
---|---|
Experimental: PTHrP 400 mcg/day
Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
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Drug: Parathyroid hormone related protein (1-36)
PTHrP (1-36) 400 micrograms / day administered subcutaneously for 3 months
Other Names:
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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:
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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.
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Drug: Parathyroid hormone (1-34)
PTH(1-34)20 micrograms subcutaneously administered daily for 3 months
Other Names:
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- 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 ]
- 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

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Ages Eligible for Study: | 45 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

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
United States, Pennsylvania | |
UPMC Clinical & Translational Research Center | |
Pittsburgh, Pennsylvania, United States, 15213 |
Principal Investigator: | Mara J Horwitz, MD | University of Pittsburgh |
Additional Information:
Publications:
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 |