OsteoporosisEarly Phase 1NCT00580788

One Week Parathyroid Hormone-related Protein (PTHrP) IV Dose Escalation Study

A Early Phase 1 study testing PTHrP (1-36) in people with Osteoporosis and Humoral Hypercalcemia of Malignancy, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 24 to 35 yearsHealthy volunteers can take part
Conditions the study is for: Osteoporosis, Humoral Hypercalcemia of Malignancy, Hyperparathyroidism
What is being tested?: PTHrP (1-36)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteUnited States
Study dates: Jan 2008to Dec 2009
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 24 to 35 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: Determining the Maximal Safe Dose of a Continuous Infusion of Parathyroid Hormone-related Protein(1-36): Effects on Bone Formation

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.

Read the detailed description

During this research the investigators administer PTHrP to healthy young volunteers in a controlled, continuous intravenous manner. As research subjects complete the week-long study without adverse effects, the dose of PThrP will be increased in later subjects. In the event of a significant adverse effect, immediate action will be taken to reverse it. The investigators want to estimate the effect of a sustainable level of mild hypercalcemia achieved by a week-long intravenous infusion of PTHrP has on vitamin D metabolism, markers of bone turnover and fractional excretion of calcium.

Conditions: Osteoporosis, Humoral Hypercalcemia of Malignancy, Hyperparathyroidism
Being tested: PTHrP (1-36)
Keywords: Endocrine System Diseases, MusculoSkeletal System Diseases, Hormones, Malignancy, Postmenopausal Women, Bone metabolism
Medical subject headings: Osteoporosis, Humoral Hypercalcemia Of Malignancy, Hyperparathyroidism, Endocrine System Diseases, Musculoskeletal Diseases, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PTHrP (1-36)Drug
Also called Parathyroid Hormone-related Protein (1-36)
IND # 49,175

Study groups in NCT00580788
Study group	Role	What they receive
PTHrP(1-36) 2 pmol/kg/hr	Experimental	PTHrP(1-36) at 2 picomoles/kg/hr for one week. Receives: Drug: PTHrP (1-36)
PTHrP (1-36) 4 pmol/kg/hr	Experimental	PTHrP(1-36) at 4 picomoles/kg/hr for one week. Receives: Drug: PTHrP (1-36)
PTHrP(1-36) 5 pmol/kg/hr	Experimental	PTHrP(1-36) at 5 picomoles/kg/hr for one week. Receives: Drug: PTHrP (1-36)
PTHrP(1-36) 6 pmol/kg/hr	Experimental	PTHrP(1-36) at 6 picomoles/kg/hr for one week. Receives: Drug: PTHrP (1-36)

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose Limiting Toxicity (DLT)
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.
Measured: 12 hours after the infusion was started then q 8 hours for 7 days
Total Serum Calcium
mg/dl
Measured: 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete
Ionized Serum Calcium
mg/dl
Measured: 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete
Serum Phosphorous
mg/dl
Measured: 12 hours after the infusion was started then q 8 hours for 7 days, Follow-up 1 week after infusion complete

Secondary outcomes (9)

1,25 Vitamin D
pg/ml
Measured: Baseline and Daily through day 8 then at follow-up visit
24 Hour Urine Calcium
mg/gm creatinine collected on day 7 of PTHrP infusion
Measured: 24 hours
Tubular Maximum of Phosphorous (TmP/GFR)
mg/dl calculated from daily second morning void
Measured: daily
Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)
% change from baseline
Measured: Baseline, Daily, and 1 week follow-up
Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)
% change from baseline
Measured: Baseline, Daily, and 1 week follow-up
Amino-terminal Peptides of Procollagen 1 (P1NP)
% change from baseline
Measured: Baseline, Daily, and 1 week follow-up
Bone Specific Alkaline Phosphatase (BSAP)
% change from baseline
Measured: Baseline, Daily, and 1 week follow-up
Parathyroid Hormone (1-84)
pg/ml
Measured: Baseline and Daily
Fractional Excretion of Calcium
% calculated from daily second morning void
Measured: daily

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Dec 2009

First posted27 Dec 2007 (estimated)
Study startJan 2008
Primary completionDec 2009
Study completionDec 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (27)Papers the sponsor has linked to this study.
Other trials for OsteoporosisStudies of the same condition, open and under way.
More trials run by University of PittsburghThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Allocation: Non-randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00580788
Sponsor's protocol ID: PRO07040081
Other IDs: R01DK073039
Status last verified: Feb 2016
First submitted: 20 Dec 2007
Last updated: 11 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Juppner H, Abou-Samra AB, Freeman M, Kong XF, Schipani E, Richards J, Kolakowski LF Jr, Hock J, Potts JT Jr, Kronenberg HM, et al. A G protein-linked receptor for parathyroid hormone and parathyroid hormone-related peptide. Science. 1991 Nov 15;254(5034):1024-6. doi: 10.1126/science.1658941.
PubMed 1658941
Orloff JJ, Wu TL, Heath HW, Brady TG, Brines ML, Stewart AF. Characterization of canine renal receptors for the parathyroid hormone-like protein associated with humoral hypercalcemia of malignancy. J Biol Chem. 1989 Apr 15;264(11):6097-103.
PubMed 2539369
Orloff JJ, Ribaudo AE, McKee RL, Rosenblatt M, Stewart AF. A pharmacological comparison of parathyroid hormone receptors in human bone and kidney. Endocrinology. 1992 Oct;131(4):1603-11. doi: 10.1210/endo.131.4.1327716.
PubMed 1327716
Orloff JJ, Reddy D, de Papp AE, Yang KH, Soifer NE, Stewart AF. Parathyroid hormone-related protein as a prohormone: posttranslational processing and receptor interactions. Endocr Rev. 1994 Feb;15(1):40-60. doi: 10.1210/edrv-15-1-40.
PubMed 8156938
Samuels MH, Veldhuis J, Cawley C, Urban RJ, Luther M, Bauer R, Mundy G. Pulsatile secretion of parathyroid hormone in normal young subjects: assessment by deconvolution analysis. J Clin Endocrinol Metab. 1993 Aug;77(2):399-403. doi: 10.1210/jcem.77.2.8345044.
PubMed 8345044
Prank K, Nowlan SJ, Harms HM, Kloppstech M, Brabant G, Hesch RD, Sejnowski TJ. Time series prediction of plasma hormone concentration. Evidence for differences in predictability of parathyroid hormone secretion between osteoporotic patients and normal controls. J Clin Invest. 1995 Jun;95(6):2910-9. doi: 10.1172/JCI117998.
PubMed 7769133
Schmitt CP, Obry J, Feneberg R, Veldhuis JD, Mehls O, Ritz E, Schaefer F. Beta1-adrenergic blockade augments pulsatile PTH secretion in humans. J Am Soc Nephrol. 2003 Dec;14(12):3245-50. doi: 10.1097/01.asn.0000101240.47747.7f.
PubMed 14638923
Chapotot F, Gronfier C, Spiegel K, Luthringer R, Brandenberger G. Relationships between intact parathyroid hormone 24-hour profiles, sleep-wake cycle, and sleep electroencephalographic activity in man. J Clin Endocrinol Metab. 1996 Oct;81(10):3759-65. doi: 10.1210/jcem.81.10.8855835.
PubMed 8855835
Harms HM, Schlinke E, Neubauer O, Kayser C, Wustermann PR, Horn R, Kulpmann WR, von zur Muhlen A, Hesch RD. Pulse amplitude and frequency modulation of parathyroid hormone in primary hyperparathyroidism. J Clin Endocrinol Metab. 1994 Jan;78(1):53-7. doi: 10.1210/jcem.78.1.8288713.
PubMed 8288713
Ledger GA, Burritt MF, Kao PC, O'Fallon WM, Riggs BL, Khosla S. Role of parathyroid hormone in mediating nocturnal and age-related increases in bone resorption. J Clin Endocrinol Metab. 1995 Nov;80(11):3304-10. doi: 10.1210/jcem.80.11.7593443.
PubMed 7593443
el-Hajj Fuleihan G, Klerman EB, Brown EN, Choe Y, Brown EM, Czeisler CA; New Collective Author. The parathyroid hormone circadian rhythm is truly endogenous--a general clinical research center study. J Clin Endocrinol Metab. 1997 Jan;82(1):281-6. doi: 10.1210/jcem.82.1.3683.
PubMed 8989274
Plawner LL, Philbrick WM, Burtis WJ, Broadus AE, Stewart AF. Cell type-specific secretion of parathyroid hormone-related protein via the regulated versus the constitutive secretory pathway. J Biol Chem. 1995 Jun 9;270(23):14078-84. doi: 10.1074/jbc.270.23.14078.
PubMed 7775469
Horwitz MJ, Tedesco MB, Sereika SM, Hollis BW, Garcia-Ocana A, Stewart AF. Direct comparison of sustained infusion of human parathyroid hormone-related protein-(1-36) [hPTHrP-(1-36)] versus hPTH-(1-34) on serum calcium, plasma 1,25-dihydroxyvitamin D concentrations, and fractional calcium excretion in healthy human volunteers. J Clin Endocrinol Metab. 2003 Apr;88(4):1603-9. doi: 10.1210/jc.2002-020773.
PubMed 12679445
Syed MA, Horwitz MJ, Tedesco MB, Garcia-Ocana A, Wisniewski SR, Stewart AF. Parathyroid hormone-related protein-(1--36) stimulates renal tubular calcium reabsorption in normal human volunteers: implications for the pathogenesis of humoral hypercalcemia of malignancy. J Clin Endocrinol Metab. 2001 Apr;86(4):1525-31. doi: 10.1210/jcem.86.4.7406.
PubMed 11297578
Everhart-Caye M, Inzucchi SE, Guinness-Henry J, Mitnick MA, Stewart AF. Parathyroid hormone (PTH)-related protein(1-36) is equipotent to PTH(1-34) in humans. J Clin Endocrinol Metab. 1996 Jan;81(1):199-208. doi: 10.1210/jcem.81.1.8550752.
PubMed 8550752

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Determining the Maximal Safe Dose of a Continuous Infusion of Parathyroid Hormone-related Protein(1-36): Effects on Bone Formation
ClinicalTrials.gov ID: NCT00580788
Acronym / sponsor ID: PRO07040081
Conditions: Osteoporosis, Humoral Hypercalcemia of Malignancy, Hyperparathyroidism
Keywords: Endocrine System Diseases, MusculoSkeletal System Diseases, Hormones, Malignancy, Postmenopausal Women, Bone metabolism
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study start: Jan 2008
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 27 Dec 2007 (estimated)
Results: Posted 11 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Allocation: Non-randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 4

Arm	Type	Receives
PTHrP(1-36) 2 pmol/kg/hr	Experimental	Drug: PTHrP (1-36)PTHrP(1-36) at 2 picomoles/kg/hr for one week.
PTHrP (1-36) 4 pmol/kg/hr	Experimental	Drug: PTHrP (1-36)PTHrP(1-36) at 4 picomoles/kg/hr for one week.
PTHrP(1-36) 5 pmol/kg/hr	Experimental	Drug: PTHrP (1-36)PTHrP(1-36) at 5 picomoles/kg/hr for one week.
PTHrP(1-36) 6 pmol/kg/hr	Experimental	Drug: PTHrP (1-36)PTHrP(1-36) at 6 picomoles/kg/hr for one week.

Who may qualify

Ages: 24 to 35 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PTHrP (1-36)Also: Parathyroid Hormone-related Protein (1-36)IND # 49,175	Drug	PTHrP (1-36) 4 pmol/kg/hr, PTHrP(1-36) 2 pmol/kg/hr, PTHrP(1-36) 5 pmol/kg/hr, PTHrP(1-36) 6 pmol/kg/hr

Primary outcome

Dose Limiting Toxicity (DLT)
Time frame: 12 hours after the infusion was started then q 8 hours for 7 days
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
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
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
mg/dl

9 secondary outcomes

1,25 Vitamin D
Time frame: Baseline and Daily through day 8 then at follow-up visit
24 Hour Urine Calcium
Time frame: 24 hours
Tubular Maximum of Phosphorous (TmP/GFR)
Time frame: daily
Serum Amino-terminal Telopeptide of Collagen -1 (sNTX)
Time frame: Baseline, Daily, and 1 week follow-up
Serum Carboxy-terminal Telopeptide of Collagen -1 (sCTX)
Time frame: Baseline, Daily, and 1 week follow-up
Amino-terminal Peptides of Procollagen 1 (P1NP)
Time frame: Baseline, Daily, and 1 week follow-up
Bone Specific Alkaline Phosphatase (BSAP)
Time frame: Baseline, Daily, and 1 week follow-up
Parathyroid Hormone (1-84)
Time frame: Baseline and Daily
Fractional Excretion of Calcium
Time frame: daily

Results and safety

Results posted to the registry on 11 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1	3	3
Group 2	6	6
Group 3	3	3
Group 4	2	1

Primary outcome: Dose Limiting Toxicity (DLT)

Time frame: 12 hours after the infusion was started then q 8 hours for 7 days. Number. Unit: participants

Measure	Group 1 n = 3	Group 2 n = 6	Group 3 n = 3	Group 4 n = 2
Value	0	0	2	2

Primary outcome: 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. Mean (Standard Error). Unit: mg/dl

Measure	Group 1 n = 3	Group 2 n = 6	Group 3 n = 3	Group 4 n = 0
baseline	9.37 (0.07)	9.58 (0.12)	9.2 (0.25)	–
11P DAY 1	9.67 (0.09)	9.80 (0.16)	9.67 (0.20)	–
7A DAY 2	9.4 (0.17)	10.05 (0.19)	10.17 (0.20)	–
3P DAY 2	9.57 (0.09)	10.28 (0.14)	10.47 (0.30)	–
11P DAY 2	9.67 (0.09)	10.32 (0.14)	10.23 (0.26)	–
7A DAY 3	9.6 (0.10)	10.40 (0.18)	10.73 (0.57)	–
3P DAY 3	9.73 (0.09)	10.42 (0.14)	10.67 (0.27)	–
11P DAY 3	9.40 (0.17)	9.73 (0.10)	9.93 (0.38)	–

Group 2: p <0.0001, Mixed Models Analysis

Primary outcome: 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. Mean (Standard Error). Unit: mg/dl

Measure	Group 1 n = 3	Group 2 n = 6	Group 3 n = 3	Group 4 n = 0
baseline	4.79 (0.03)	4.72 (0.08)	4.55 (0.15)	–
11P DAY 1	4.51 (0.05)	4.77 (0.08)	4.75 (0.04)	–
7A DAY 2	4.77 (0.07)	4.98 (0.10)	5.07 (0.07)	–
3P DAY 2	4.52 (0.02)	4.99 (0.06)	5.07 (0.06)	–
11P DAY 2	4.48 (0.08)	5.04 (0.07)	4.84 (0.00)	–
7A DAY 3	4.77 (0.15)	5.31 (0.08)	5.25 (0.13)	–
3P DAY 3	4.73 (0.11)	4.99 (0.10)	4.91 (0.16)	–
11P DAY 3	4.41 (0.15)	4.58 (0.15)	4.83 (0.14)	–

Group 2: p <0.0001, Mixed Models Analysis

Primary outcome: 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. Mean (Standard Error). Unit: mg/dl

Measure	Group 1 n = 3	Group 2 n = 6	Group 3 n = 3	Group 4 n = 0
baseline	3.55 (0.15)	3.63 (0.14)	3.55 (0.45)	–
11P DAY 1	3.87 (0.26)	3.90 (0.16)	4.03 (0.12)	–
7A DAY 2	4.07 (0.15)	4.20 (0.15)	3.63 (0.44)	–
3P DAY 2	3.63 (0.33)	3.50 (0.23)	3.70 (0.20)	–
11P DAY 2	4.13 (0.29)	3.52 (0.19)	3.63 (0.19)	–
7A DAY 3	3.90 (0.26)	3.77 (0.19)	3.43 (0.39)	–
3P DAY 3	3.53 (0.24)	3.53 (0.18)	3.60 (0.23)	–
11P DAY 3	4.03 (0.26)	3.58 (0.17)	3.70 (0.15)	–

Group 1 vs Group 2 vs Group 3: p >.05, Mixed Models Analysis

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Subjects were systematically assessed every 8 hours for adverse events. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1	0 of 3 (0%)	0 of 3 (0%)	Not reported
Group 2	0 of 6 (0%)	0 of 6 (0%)	Not reported
Group 3	0 of 3 (0%)	1 of 3 (33.3%)	Not reported
Group 4	0 of 2 (0%)	2 of 2 (100%)	Not reported

Limitations and caveats (from the sponsor): Small number of subjects in each group Study limited to Caucasians Only one timepoint for follow-up was measure Study did not include saline infused controls

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 1658941Juppner H, Abou-Samra AB, Freeman M, Kong XF, Schipani E, Richards J, Kolakowski LF Jr, Hock J, Potts JT Jr, Kronenberg HM, et al. A G protein-linked receptor for parathyroid hormone and parathyroid hormone-related peptide. Science. 1991 Nov 15;254(5034):1024-6. doi: 10.1126/science.1658941.
Background: PubMed 2539369Orloff JJ, Wu TL, Heath HW, Brady TG, Brines ML, Stewart AF. Characterization of canine renal receptors for the parathyroid hormone-like protein associated with humoral hypercalcemia of malignancy. J Biol Chem. 1989 Apr 15;264(11):6097-103.
Background: PubMed 1327716Orloff JJ, Ribaudo AE, McKee RL, Rosenblatt M, Stewart AF. A pharmacological comparison of parathyroid hormone receptors in human bone and kidney. Endocrinology. 1992 Oct;131(4):1603-11. doi: 10.1210/endo.131.4.1327716.
Background: PubMed 8156938Orloff JJ, Reddy D, de Papp AE, Yang KH, Soifer NE, Stewart AF. Parathyroid hormone-related protein as a prohormone: posttranslational processing and receptor interactions. Endocr Rev. 1994 Feb;15(1):40-60. doi: 10.1210/edrv-15-1-40.
Background: PubMed 8345044Samuels MH, Veldhuis J, Cawley C, Urban RJ, Luther M, Bauer R, Mundy G. Pulsatile secretion of parathyroid hormone in normal young subjects: assessment by deconvolution analysis. J Clin Endocrinol Metab. 1993 Aug;77(2):399-403. doi: 10.1210/jcem.77.2.8345044.
Background: PubMed 7769133Prank K, Nowlan SJ, Harms HM, Kloppstech M, Brabant G, Hesch RD, Sejnowski TJ. Time series prediction of plasma hormone concentration. Evidence for differences in predictability of parathyroid hormone secretion between osteoporotic patients and normal controls. J Clin Invest. 1995 Jun;95(6):2910-9. doi: 10.1172/JCI117998.
Background: PubMed 14638923Schmitt CP, Obry J, Feneberg R, Veldhuis JD, Mehls O, Ritz E, Schaefer F. Beta1-adrenergic blockade augments pulsatile PTH secretion in humans. J Am Soc Nephrol. 2003 Dec;14(12):3245-50. doi: 10.1097/01.asn.0000101240.47747.7f.
Background: PubMed 8855835Chapotot F, Gronfier C, Spiegel K, Luthringer R, Brandenberger G. Relationships between intact parathyroid hormone 24-hour profiles, sleep-wake cycle, and sleep electroencephalographic activity in man. J Clin Endocrinol Metab. 1996 Oct;81(10):3759-65. doi: 10.1210/jcem.81.10.8855835.
Background: PubMed 8288713Harms HM, Schlinke E, Neubauer O, Kayser C, Wustermann PR, Horn R, Kulpmann WR, von zur Muhlen A, Hesch RD. Pulse amplitude and frequency modulation of parathyroid hormone in primary hyperparathyroidism. J Clin Endocrinol Metab. 1994 Jan;78(1):53-7. doi: 10.1210/jcem.78.1.8288713.
Background: PubMed 7593443Ledger GA, Burritt MF, Kao PC, O'Fallon WM, Riggs BL, Khosla S. Role of parathyroid hormone in mediating nocturnal and age-related increases in bone resorption. J Clin Endocrinol Metab. 1995 Nov;80(11):3304-10. doi: 10.1210/jcem.80.11.7593443.
Background: PubMed 8989274el-Hajj Fuleihan G, Klerman EB, Brown EN, Choe Y, Brown EM, Czeisler CA; New Collective Author. The parathyroid hormone circadian rhythm is truly endogenous--a general clinical research center study. J Clin Endocrinol Metab. 1997 Jan;82(1):281-6. doi: 10.1210/jcem.82.1.3683.
Background: PubMed 7775469Plawner LL, Philbrick WM, Burtis WJ, Broadus AE, Stewart AF. Cell type-specific secretion of parathyroid hormone-related protein via the regulated versus the constitutive secretory pathway. J Biol Chem. 1995 Jun 9;270(23):14078-84. doi: 10.1074/jbc.270.23.14078.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mara J Horwitz, MD principal investigator

University of Pittsburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing PTHrP (1-36) in people with Osteoporosis and Humoral Hypercalcemia of Malignancy, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicity (DLT) (time frame: 12 hours after the infusion was started then q 8 hours for 7 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00580788, which also lists 27 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2016.