Primary outcomeNumber· 8 Weeks
Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 8, Based on Investigator Prescribed Data.
| Group | Value (percentage of participants) |
|---|---|
| NPSP558 - 25 µg Dose | 21.1 |
| NPSP558 - 50 µg Dose | 26.1 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataStudy of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY)
NCTNCT01268098 (opens ClinicalTrials.gov in a new tab)Other idPAR-C10-007
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 42 participants (actual)
- Sponsor
- Shire · Industry
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- 9 Feb 2011
- Primary completion
- 23 Sept 2011
- Completion
- 11 Nov 2011
- First posted
- 29 Dec 2010 (estimated)
- Last update posted
- 11 Jun 2021
- Conditions
- Hypoparathyroidism
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
20112012
- Ph 3
Study of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY)
NCT012680989 Feb 2011 to 11 Nov 2011
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Use of PTH (1-84) a recombinant hormone in 25 µg or 50 µg doses for the treatment of adults with hypoparathyroidism. The use of PTH (1-84) should result in a decrease of calcium and vitamin D supplements.
Interventions
- NPSP558Drug
Arms2
Experimental
25 µg dose
25 µg
Experimental
50 µg dose
50 µg
Primary outcomes1
Outcomes the sponsor listed as primary.
Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 8, Based on Investigator Prescribed Data.
Time frame · 8 Weeks
Registry description
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.
Secondary outcomes(1)
The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 8.
Time frame · 8 Weeks
Registry description
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
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(1)
Secondary outcomeNumber· 8 Weeks
The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 8.
| Group | Value (percentage of participants) |
|---|---|
| NPSP558 - 25 µg Dose | 10.5 |
| NPSP558 - 50 µg Dose | 26.1 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| NPSP558 - 25 µg DoseNPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 25 mcg subcutaneously daily | – | 0 / 19 | 11 / 19 |
| NPSP558 - 50 µg DoseNPSP558: Recombinant Human Parathyroid hormone (rhPTH\[1-84\]) 50 mcg subcutaneously daily | – | 0 / 23 | 17 / 23 |
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
Studies5
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2017
6 results
Safety and Efficacy of Recombinant Human Parathyroid Hormone in Adults With Hypoparathyroidism Randomly Assigned to Receive Fixed 25-μg or 50-μg Daily Doses.
Bilezikian et al. 2017Clinical therapeuticscited by 15
PMID 28942334DOI 10.1016/j.clinthera.2017.08.011PUB-28942334
Free to read · publisher termsCC BY-NC-ND6 results
More studies
4 studies on this page
PubMed tag: none · 2023
The risk of chronic kidney disease development in adult patients with chronic hypoparathyroidism treated with rhPTH(1-84): A retrospective cohort study.
Rejnmark et al. 2023Clinical endocrinologycited by 12
PMID 35974422DOI 10.1111/cen.14813PUB-35974422
Free to read · publisher termsCC BY-NC-ND
PubMed tag: none · 2022
Lower Risk of Cardiovascular Events in Adult Patients with Chronic Hypoparathyroidism Treated with rhPTH(1-84): A Retrospective Cohort Study.
Ayodele et al. 2022Advances in therapycited by 6
PMID 35696069PMC9309129DOI 10.1007/s12325-022-02198-yPUB-35696069
Free to read · publisher termsCC BY-NC
PubMed tag: none · 2022
Five-Year Estimated Glomerular Filtration Rate in Adults with Chronic Hypoparathyroidism Treated with rhPTH(1-84): A Retrospective Cohort Study.
Ayodele et al. 2022Advances in therapycited by 10
PMID 36018496PMC9525348DOI 10.1007/s12325-022-02292-1PUB-36018496
Free to read · publisher termsCC BY-NC
Indexing hint: Observational study · 2020
Five-year Estimated Glomerular Filtration Rate in Patients With Hypoparathyroidism Treated With and Without rhPTH(1-84).
Chen et al. 2020The Journal of clinical endocrinology and metabolismcited by 28
PMID 32738041PMC7470469DOI 10.1210/clinem/dgaa490PUB-32738041
CC BY
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 85 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Main Inclusion Criteria:
1. Previously completed 24 weeks of therapy and 4 weeks of follow-up in the REPLACE study
2. 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
3. Total serum calcium ≤ ULN based on local laboratory results prior to randomization
4. Serum 25(OH) vitamin D ≤ 1.5 times the ULN within approximately 8 weeks prior to randomization
Main Exclusion Criteria:
1. 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
2. Use of raloxifene hydrochloride or intravenous (IV) bisphosphonates since the end of participation in the REPLACE trial
3. Chronic (ie, ≥ 1 month exposure) use of systemic corticosteroids, oral bisphosphonates, calcitonin, fluoride tablets, or cinacalcet hydrochloride
4. Pregnant or lactating women
5. Any condition that would, in the investigator's opinion in consultation with the sponsor, preclude the safe use of PTH
6. Use of any experimental drug other than NPSP558 within 3 months of baseline.
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