Phase 2
N=105
Comparison Study of PTHrP and PTH to Treat Osteoporosis
Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00853723 ↗Enrolled (actual)
105
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Procallagen-1 Amino-terminal Peptide (P1NP) — 32.54; 23.51; 60.67; 48.89 percentage change from baseline — p=<0.0005
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Parathyroid hormone related protein (1-36) (Drug); Parathyroid hormone related protein(1-36) (Drug); Parathyroid hormone (1-34) (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Female
- Sponsor
- University of Pittsburgh
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Procallagen-1 Amino-terminal Peptide (P1NP) |
32.54; 23.51; 60.67; 48.89; 83.14; 97.27 | <0.0005 sig |
| PRIMARY Carboxy-terminal Telopeptides of Collagen-1 (CTX) |
-12.40; 10.25; 4.87; 1.60; 9.59; 13.89 | <0.05 sig |
| SECONDARY Changes in Bone Mineral Density of the Lumbar Spine. |
1.89; 1.52; 2.17 | <0.05 sig |
| SECONDARY Changes in Bone Mineral Density of the Total Hip. |
0.68; 0.72; 0.54 | <0.05 sig |
| SECONDARY Changes in Bone Mineral Density of the Femoral Neck. |
0.91; 0.54; 0.61 | <0.05 sig |
| SECONDARY Changes in Bone Mineral Density of the Forearm. |
-0.48; -0.99; -0.97 | >0.05 |
| SECONDARY Changes in Bone Mineral Density of the Distal 1/3 Radius. |
-0.35; -0.34; -0.82 | >0.05 |
| SECONDARY Total Serum Calcium (mg/dl) |
9.48; 9.51; 9.49; 9.95; 9.87; 9.57 | <0.0005 sig |
| SECONDARY Serum Phosphorous |
4.0; 3.93; 4.09; 3.78; 3.68; 4.13 | <0.05 sig |
| SECONDARY 24 Hour Urine Calcium |
206.37; 213.07; 209.99; 260.46; 235.25; 232.48 | <0.005 sig |
| SECONDARY 1,25 Vitamin D |
49.06; 42.49; 42.51; 84.92; 63.07; 65.25 | <0.05 sig |
| SECONDARY Fractional Excretion of Calcium |
2.38; 2.71; 2.30; 3.42; 4.18; 2.55 | <0.05 sig |
| SECONDARY Tubular Maximum for Phosphorous/Glomerular Filtration Rate (TMP/GFR) |
3.80; 3.71; 3.96; 3.78; 3.47; 4.18 | <0.05 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00853723). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.