Early Phase 1
N=14
One Week Parathyroid Hormone-related Protein (PTHrP) IV Dose Escalation Study
Osteoporosis · Humoral Hypercalcemia of Malignancy · Hyperparathyroidism
Bottom Line
View on ClinicalTrials.gov: NCT00580788 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Dose Limiting Toxicity (DLT) — 0; 0; 2; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- PTHrP (1-36) (Drug)
- Age
- Adult · 24+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dose Limiting Toxicity (DLT) |
0; 0; 2; 2 | — |
| PRIMARY Total Serum Calcium |
9.37; 9.58; 9.2; 9.67; 9.80; 9.67 | <0.0001 sig |
| PRIMARY Ionized Serum Calcium |
4.79; 4.72; 4.55; 4.51; 4.77; 4.75 | <0.0001 sig |
| PRIMARY Serum Phosphorous |
3.55; 3.63; 3.55; 3.87; 3.90; 4.03 | >.05 |
| SECONDARY 1,25 Vitamin D |
34.13; 45.08; 39.0; 38.40; 45.88; 39.77 | >0.05 |
| SECONDARY 24 Hour Urine Calcium |
121.64; 283.43; 320.23 | — |
| SECONDARY Tubular Maximum of Phosphorous (TmP/GFR) |
3.43; 3.91; 3.38; 4.48; 4.08; 3.47 | 0.61 |
| SECONDARY Serum Amino-terminal Telopeptide of Collagen -1 (sNTX) |
0.00; 0.00; 0.00; 32.86; 87.75; 54.21 | <.008 sig |
| SECONDARY Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX) |
0.00; 0.00; 0.00; 59.78; 147.12; 105.06 | <.0001 sig |
| SECONDARY Amino-terminal Peptides of Procollagen 1 (P1NP) |
0.00; 0.00; 0.00; -1.05; -17.49; -23.88 | <.0001 sig |
| SECONDARY Bone Specific Alkaline Phosphatase (BSAP) |
0.00; 0.00; 0.00; -12.53; -1.17; 24.54 | 0.001 sig |
| SECONDARY Parathyroid Hormone (1-84) |
42.97; 30.70; 48.27; 23.47; 7.82; 3.60 | <0.05 sig |
| SECONDARY Fractional Excretion of Calcium |
1.93; 2.57; 2.38; 1.31; 2.26; 4.11 | .002 sig |
Summary
This is a dose escalation study to determine the maximum tolerable dose of Parathyroid Hormone-related Protein, PTHrP, that can be given safely over one week. The investigators plan to infuse low doses of intravenous PTHrP to determine if it leads to a sustained and progressive suppression of bone formation as occurs in humoral hypercalcemia of malignancy (HHM) or an increase in bone formation as occurs in hyperparathyroidism (HPT). Additionally, the investigators will assess the direct influence of PTHrp on markers of bone turnover, and plasma 1,25 (OH)2 vitamin D regulation in healthy human volunteers.
Eligibility Criteria
Inclusion Criteria
- Healthy caucasian subjects of both sexes between the ages of 24-35 years, who are able to spend one week on the Clinical & Translational Research Center at the University of Pittsburgh Medical Center (UPMC) Montefiore
Exclusion Criteria
- Pregnancy
- Any cardiac, renal, pulmonary, endocrine, musculoskeletal, hepatic, hematological, malignant or rheumatologic diseases
- Body mass index great than 30
- Anemia
- Significant alcohol or drug abuse
- Baseline hypotension or hypertension
- Abnormal screening labs
- Use of certain chronic medications excluding oral contraceptives
- Receiving an investigational drug in the last 90 days
- Previously receiving PTH or PTHrP
- African-American race
Data sourced from ClinicalTrials.gov (NCT00580788). 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.