Primary outcomeNumber· 12 hours after the infusion was started then q 8 hours for 7 days
Participants With Dose Limiting Toxicity
| Group | Value (participants) |
|---|---|
| Group 1 | 0 |
| Group 2 | 2 |
Trial · Interventional
CompletedEarly phase 1Results postedRegistry data7 Day Continuous Parathyroid Hormone IV Infusion
This trial does not test a peptide that PepBank tracks.
- Names Teriparatide (PTH 1-34), does not test it. It appears in the summary.
Overview
- Status
- Completed
- Phase
- Early phase 1
- Enrollment
- 11 participants (actual)
- Sponsor
- University of Pittsburgh · Other
- Design
- Allocation not applicable · Single masking
- Countries
1 country
United States
- Start
- Sept 2006
- Primary completion
- Dec 2007
- Completion
- Dec 2007
- First posted
- 18 Sept 2006 (estimated)
- Last update posted
- 22 Mar 2016 (estimated)
- Conditions
- Osteoporosis · Bone Diseases, Endocrine · Hyperparathyroidism
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
200620072008
- Ph Early 1
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Study consists of an eight day inpatient visit on the General Clinical Research Center. The investigators' specific aims are to: 1. To define the maximum safe dose of a seven day continuous administration of parathyroid hormone \[PTH(1-34)\] in healthy human volunteers. 2. To estimate the effect of a seven day continuous administration of parathyroid Hormone (PTH) in escalating doses on vitamin D metabolism, markers of bone turnover and fractional excretion of urine.
Interventions
- Parathyroid Hormone (1-34)Drug
Arms2
Experimental
Group 1
Parathyroid Hormone (PTH) (1-34) 2 picomols/kg/hr for one week.
Experimental
Group 2
Parathyroid Hormone (PTH) (1-34)4 picomols/kg/hr for one week.
Primary outcomes4
Outcomes the sponsor listed as primary.
Participants With Dose Limiting Toxicity
Time frame · 12 hours after the infusion was started then q 8 hours for 7 days
Registry description
DLT was defined as achieving one major criterion or two minor criteria rated at ≥ 2 on a scale of 0-5. The major criteria were defined as symptomatic orthostatic hypotension (systolic BP fall \>30 mm/hg), tachycardia (pulse \> 120), hypertension (systolic BP \>160 mm/hg on 2 occasions), hypercalcemia (serum calcium ≥ 12 mg/dl), and hypophosphatemia (serum phosphorous \< 1.5 mg/dl). Minor criteria included symptoms such as flushing, nausea, abdominal or muscle cramps, dizziness, lightheadedness, palpitations, etc.
Total Serum Calcium
Time frame · 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete
Registry description
mg/dl
Ionized Serum Calcium
Time frame · 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete
Registry description
mg/dl
Serum Phosphorous
Time frame · 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete
Registry description
mg/dl
Secondary outcomes(9)
1,25 Vitamin D
Time frame · baseline, daily up to Day 8 and follow-up
Registry description
pg/ml
Parathyroid Hormone (1-84)
Time frame · baseline, daily up to Day 8 and follow-up
Registry description
pg/ml
Fractional Excretion of Calcium
Time frame · baseline and daily
Registry description
% = (S Creatinine X U Calcium)/(S Calcium X U Creatinine)
24 Hour Urine Calcium
Time frame · 24 hours period from Day 7 to Day 8
Registry description
mg/gm creatinine
Tubular Maximum for Phosphorous
Time frame · baseline and daily
Registry description
mg/dl
Serum Amino-terminal of Collagen- (sNTX)
Time frame · baseline, daily, one week follow-up
Registry description
% change from baseline
Serum Carboxy-terminal of Collagen- 1(sCTX)
Time frame · baseline, daily, one week follow-up
Registry description
% change from baseline
Amino-terminal Peptides of Procollagen- 1(P1NP)
Time frame · baseline, daily, one week follow-up
Registry description
% change from baseline
Bone Specific Alkaline Phosphatase (BSAP)
Time frame · baseline, daily, one week follow-up
Registry description
% change from baseline
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMean· 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete
Total Serum Calcium
| Group | Value (mg/dl) | Spread |
|---|---|---|
| Group 1 | 9.33 | 0.20 |
| Group 2 | 9.11 | 0.16 |
Primary outcomeMean· 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete
Ionized Serum Calcium
| Group | Value (mg/dl) | Spread |
|---|---|---|
| Group 1 | 4.72 | 0.10 |
| Group 2 | 4.52 | 0.05 |
Primary outcomeMean· 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete
Serum Phosphorous
| Group | Value (mg/dl) | Spread |
|---|---|---|
| Group 1 | 3.51 | 0.30 |
| Group 2 | 3.45 | 0.28 |
Secondary and other outcome results(4)
Secondary outcomeMean· baseline, daily up to Day 8 and follow-up
1,25 Vitamin D
| Group | Value (pg/ml) | Spread |
|---|---|---|
| Group 1 | 37.78 | 4.71 |
| Group 2 | 39.18 | 5.82 |
Secondary outcomeMean· baseline, daily up to Day 8 and follow-up
Parathyroid Hormone (1-84)
| Group | Value (pg/ml) | Spread |
|---|---|---|
| Group 1 | 20.90 | 3.85 |
| Group 2 | 52.44 | 12.88 |
Secondary outcomeMean· baseline and daily
Fractional Excretion of Calcium
| Group | Value (% of excretion) | Spread |
|---|---|---|
| Group 1 | 3.38 | 1.42 |
| Group 2 | 1.80 | 0.41 |
Secondary outcomeMean· 24 hours period from Day 7 to Day 8
24 Hour Urine Calcium
| Group | Value (mg/gm creatinine) | Spread |
|---|---|---|
| Group 1 | 315.278845 | 25.0352949 |
| Group 2 | 210.24827 | 58.3459645 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Group 1PTH (1-34) 2 picomoles (pmols)/kg/hr | – | 0 / 6 | 1 / 6 |
| Group 2PTH (1-34) 4 picomoles (pmols)/kg/hr | – | 0 / 5 | 2 / 5 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies2
Studies that cite this trial.
Studies with results
2 studies on this page
Indexing hint: Observational study · 2000
3 results
Six-month daily administration of parathyroid hormone and parathyroid hormone-related protein peptides to adult ovariectomized rats markedly enhances bone mass and biomechanical properties: a comparison of human parathyroid hormone 1-34, parathyroid hormone-related protein 1-36, and SDZ-parathyroid hormone 893.
Stewart et al. 2000Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Researchcited by 96
PMID 10934650DOI 10.1359/jbmr.2000.15.8.1517PUB-10934650
Full text at the publisher3 results
Indexing hint: Observational study · 1992
11 results
A comparison of the in vivo biochemical responses to exogenous parathyroid hormone-(1-34) [PTH-(1-34)] and PTH-related peptide-(1-34) in man.
Fraher et al. 1992The Journal of clinical endocrinology and metabolismcited by 32
PMID 1322424DOI 10.1210/jcem.75.2.1322424PUB-01322424
Full text at the publisher11 results
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedHorwitz MJ, Tedesco MB, Sereika SM, Prebehala L, Gundberg CM, Hollis BW, Bisello A, Garcia-Ocana A, Carneiro RM, Stewart AF. A 7-day continuous infusion of PTH or PTHrP suppresses bone formation and uncouples bone turnover. J Bone Miner Res. 2011 Sep;26(9):2287-97. doi: 10.1002/jbmr.415. PMID 21544866
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 24 Years up to 35 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* Healthy Caucasian, Hispanic or Asian subjects
* Males and Females
* Non-smoker
* Ages 24 - 35 years old
* Subjects will be recruited either from the employee pool of the University of Pittsburgh or the University of Pittsburgh Medical Center (UPMC), or the general population living in the vicinity.
* Participation in this study by an employee or a potential employee at the University of Pittsburgh or UPMC has no effect on their employment or potential employment.
* Participants in the study will be required to discontinue all vitamins and health food supplements two weeks prior to the study.
Exclusion Criteria:
* Cardiac, hypertensive, vascular, renal (serum creatinine of \>1.5), pulmonary, endocrine, musculoskeletal, hepatic, hematologic or malignant or rheumatologic disease
* Body Mass Index (BMI) \> 30,
* Anemia (hematocrit less than 36% in women, less than 40% in men),
* Pregnancy (all women will have a urine pregnancy test performed immediately before starting the study and must not be pregnant)
* Significant alcohol or drug abuse or
* Baseline hypotension (systolic blood pressure less than 90 mm/Hg).
* Subjects will be excluded for abnormal levels of any of the screening labs including: ionized and total serum calcium, phosphorus, creatinine, albumin, 25-hydroxyvitamin D, and PTH. Pregnancy
* Subjects taking any chronic medications except oral contraceptives and stable doses of thyroid hormone, or those who have received any investigational drug in past 90 days will be excluded from the study.
* Subjects may not participate in this study more than once.
* Any subject who has previously received PTH or PTHrP, a related peptide, may not participate in this study.
Minority Inclusion/Exclusion Statement: We will not include African-Americans because this group has been demonstrated by a number of investigators to display resistance to PTH, and may create wider statistical variation and a need for larger numbers of study subjects per group.
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