Study of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY)
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ClinicalTrials.gov Identifier: NCT01268098 |
Recruitment Status :
Completed
First Posted : December 29, 2010
Results First Posted : March 6, 2015
Last Update Posted : June 11, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypoparathyroidism | Drug: NPSP558 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 42 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Dose-blinded Study to Investigate the Safety and Efficacy of NPSP558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)], at Fixed Doses of 25 µg and 50 µg for the Treatment of Adults With Hypoparathyroidism |
Actual Study Start Date : | February 9, 2011 |
Actual Primary Completion Date : | September 23, 2011 |
Actual Study Completion Date : | November 11, 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: 25 µg dose
25 µg
|
Drug: NPSP558
All patients will inject NPSP558 25 or 50 µg SC QD into alternating thighs in the morning via a multidose injection pen device.
Other Name: RELAY |
Experimental: 50 µg dose
50 µg
|
Drug: NPSP558
All patients will inject NPSP558 25 or 50 µg SC QD into alternating thighs in the morning via a multidose injection pen device.
Other Name: RELAY |
- Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 8, Based on Investigator Prescribed Data. [ Time Frame: 8 Weeks ]The triple efficacy endpoint criteria were defined as a reduction from baseline in oral calcium to ≤ 500 mg/day, a reduction from baseline in calcitriol dose to ≤ 0.25 µg/day, and an albumin-corrected total serum calcium level between 7.5 mg/dL and the upper limit of the laboratory normal range. The analysis of primary endpoint was based on investigator prescribed data.
- The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 8. [ Time Frame: 8 Weeks ]The triple efficacy endpoint criteria were defined as at least a 50% reduction from the baseline in oral calcium dose and at least a 50% reduction from the baseline in active vitamin D dose and an albumin-corrected total serum calcium concentration that was maintained or normalized compared to the baseline value (≥ 7.5 mg/dL) and did not exceed the upper limit of the laboratory normal range. The analysis of primary efficacy endpoint was based on investigator prescribed data

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
- Previously completed 24 weeks of therapy and 4 weeks of follow-up in the REPLACE study
- With regard to female patients: women who are postmenopausal or willing to use two medically acceptable methods of contraception for the duration of the study with pregnancy testing conducted at every scheduled office visit
- Total serum calcium ≤ ULN based on local laboratory results prior to randomization
- Serum 25(OH) vitamin D ≤ 1.5 times the ULN within approximately 8 weeks prior to randomization
Main Exclusion Criteria:
- Any disease or condition that, in the opinion of the investigator, has a high probability of precluding the patient from completing the study or being able to appropriately comply with study requirements
- Use of raloxifene hydrochloride or intravenous (IV) bisphosphonates since the end of participation in the REPLACE trial
- Chronic (ie, ≥ 1 month exposure) use of systemic corticosteroids, oral bisphosphonates, calcitonin, fluoride tablets, or cinacalcet hydrochloride
- Pregnant or lactating women
- Any condition that would, in the investigator's opinion in consultation with the sponsor, preclude the safe use of PTH
- Use of any experimental drug other than NPSP558 within 3 months of baseline.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01268098
United States, California | |
Advance Medical Research LLC | |
Lakewood, California, United States, 90712 | |
United States, Illinois | |
University of Chicago Medical Center | |
Chicago, Illinois, United States, 60637 | |
United States, Indiana | |
Indiana University School of Medicine | |
Indianapolis, Indiana, United States, 46202 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
United States, Michigan | |
Michigan Bone & Mineral Clinic PC | |
Detroit, Michigan, United States, 48236 | |
United States, Minnesota | |
Mayo Clinic Rochester | |
Rochester, Minnesota, United States, 55905 | |
United States, New York | |
Columbia University Medical Center | |
New York, New York, United States, 10032 | |
University Physicians Group | |
Staten Island, New York, United States, 10301 | |
United States, North Carolina | |
Physician East PA | |
Greenville, North Carolina, United States, 27834 | |
United States, Ohio | |
University of Cincinnati Bone Health and Osteoporosis Center | |
Cincinnati, Ohio, United States, 45219 | |
United States, Texas | |
Cetero Research DGD Research Inc. | |
San Antonio, Texas, United States, 78229 | |
United States, Washington | |
The Vancouver Clinic | |
Vancouver, Washington, United States, 98664 |
Study Director: | Study Director | Takeda |
Responsible Party: | Shire |
ClinicalTrials.gov Identifier: | NCT01268098 |
Other Study ID Numbers: |
PAR-C10-007 |
First Posted: | December 29, 2010 Key Record Dates |
Results First Posted: | March 6, 2015 |
Last Update Posted: | June 11, 2021 |
Last Verified: | June 2021 |
Hypoparathyroidism, rhPTH[1-84], NPSP558 |
Hypoparathyroidism Parathyroid Diseases Endocrine System Diseases |