One Week Parathyroid Hormone-related Protein (PTHrP) IV Dose Escalation Study (NCT00580788) | Clinical Trial Compass
CompletedEarly Phase 1
One Week Parathyroid Hormone-related Protein (PTHrP) IV Dose Escalation Study
United States14 participantsStarted 2008-01
Plain-language 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.
Who can participate
Age range
24 Years – 35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dose Limiting Toxicity (DLT)
Timeframe: 12 hours after the infusion was started then q 8 hours for 7 days
2
Total Serum Calcium
Timeframe: 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete
3
Ionized Serum Calcium
Timeframe: 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete
4
Serum Phosphorous
Timeframe: 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete