Chronic Kidney DiseasePhase 3NCT01277510
Pediatric Chronic Kidney Disease Safety and Efficacy
A Phase 3 study testing cinacalcet capsule in people with Chronic Kidney Disease and Hyperparathyroidism, run by Amgen at 51 sites in 10 countries.
Trial summary
The purpose of this study is to assess the safety and efficacy of adding cinacalcet to the current treatment of secondary hyperparathyroidism in children currently receiving dialysis compared to a treatment regimen that does not include cinacalcet. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Chronic Kidney Disease, Hyperparathyroidism, Hyperparathyroidism, Secondary
- What is being tested?
- cinacalcet capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 51 sitesin 10 countries
- Study dates
- 28 Jun 2011to 30 Apr 2014
- Phase
- Phase 3
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6 to less than 18 years at screening
- Diagnosed with CKD and SHPT receiving hemodialysis or peritoneal dialysis for ≥ 2 months before randomization
- Dry weight ≥ 12.5 kg at screening
- iPTH obtained from the central laboratory must be > 300 pg/mL (31.8 pmol/L)
- Serum calcium (corrected) obtained from the central laboratory must be ≥ 8.8 mg/dL (2.2 mmol/L)
- Serum phosphorus obtained from the central laboratory ≥ 4.0 mg/dL (1.3 mmol/L) for children 6 to less than 12 years old, or ≥ 3.5 mg/dL (1.1 mmol/L) for children 12 to less than 18 years old
Show all 10Show fewer
- Subjects already receiving vitamin D sterols (either calcitriol or a synthetic analog), a stable dose within the last 2 months prior to randomization
- Subjects taking growth hormone, a stable dose defined as no change > than 20% in the last 2 months prior to randomization
- Subjects on anti-convulsant medication must be on a stable dose for 3 months, and have a therapeutic blood level of the anti-convulsant at the time of randomization
- Subjects must be on a dialysate calcium concentration of ≥ 2.5 mEq/L (1.25 mmol/L) for at least 2 months prior to randomization
Who cannot join
- Underwent parathyroidectomy in the last 6 months
- Anticipated parathyroidectomy within 6 months after randomization
- Received therapy with cinacalcet (sensipar/mimpara) within the last month
- A new onset of seizure or worsening of a pre-existing seizure disorder within the last 3 months
- Scheduled date for kidney transplant from a known living donor that makes completion of the study unlikely
Trial locations and contacts
51 sites in 10 countries.
51 sites in 10 countries
United States18 sites
Research Site
Baltimore, Maryland, 21287
Research Site
Birmingham, Alabama, 35233
Research Site
Boston, Massachusetts, 02115
Research Site
Charlottesville, Virginia, 22908
Research Site
Cincinnati, Ohio, 45229
Research Site
Gainesville, Florida, 32610
Research Site
Greenville, North Carolina, 27834
Research Site
Houston, Texas, 77030
Research Site
Kansas City, Missouri, 64108
Research Site
Livingston, New Jersey, 07039
Research Site
Los Angeles, California, 90095
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
Portland, Oregon, 97227
Research Site
San Antonio, Texas, 78229
Research Site
San Francisco, California, 94143
Research Site
St Louis, Missouri, 63104
Research Site
St Louis, Missouri, 63110
Research Site
The Bronx, New York, 10467
Spain6 sites
Research Site
Barakaldo, Basque Country, 48903
Research Site
Barakaldo, PaÃ-s Vasco, 48903
Research Site
Barcelona, Catalonia, 08035
Research Site
Barcelona, Cataluña, 08035
Research Site
Madrid, 28046
Research Site
Valencia, Valencia, 46026
Poland5 sites
Research Site
Gdansk, 80-952
Research Site
Gorzów Wielkopolski, 66-400
Research Site
Lodz, 93-338
Research Site
Warsaw, 00-576
Research Site
Warsaw, 04-730
Australia4 sites
Research Site
Herston, Queensland, 4029
Research Site
Parkville, Victoria, 3052
Research Site
Randwick, New South Wales, 2031
Research Site
Westmead, New South Wales, 2145
Belgium4 sites
Research Site
Brussels, 1020
Research Site
Edegem, 2650
Research Site
Ghent, 9000
Research Site
Leuven, 3000
Hungary4 sites
Research Site
Budapest, 1083
Research Site
Debrecen, 4032
Research Site
Pécs, 7623
Research Site
Szeged, 6720
Russia3 sites
Research Site
Moscow, 107014
Research Site
Saint Petersburg, 198205
Research Site
Samara, 443095
Slovakia3 sites
Research Site
Banská Bystrica, 974 09
Research Site
Bratislava, 833 40
Research Site
Košice, 040 11
Mexico2 sites
Research Site
Aguascalientes, 20219
Research Site
Mexico City, Mexico City, 04530
About this study
Official title: A Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Pediatric Subjects With Chronic Kidney Disease and Secondary Hyperparathyroidism Receiving Dialysis
The purpose of this study is to assess the safety and efficacy of adding cinacalcet to the current treatment of secondary hyperparathyroidism in children currently receiving dialysis compared to a treatment regimen that does not include cinacalcet.
Read the detailed description
Secondary hyperparathyroidism (SHPT) is a condition that can develop early in patients with chronic kidney disease (CKD), usually gets worse over time, and is known to cause problems for patients on dialysis. Children on dialysis can have a wide range of bone and growth issues, and common treatments have a chance of making these things worse by increasing serum calcium and serum phosphorus. Cinacalcet has been shown to be effective in controlling parathyroid hormone (PTH), calcium and phosphorus in adults. The purpose of this study is to show that including cinacalcet in the treatment of SHPT will lower the levels of intact parathyroid hormone (iPTH) in a larger number of pediatric patients with CKD who are receiving dialysis, compared to a treatment regimen that does not include cinacalcet.
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Hyperparathyroidism, Secondary, Kidney Disease, Secondary Hyperparathyroidism
- Being tested
- cinacalcet capsule, placebo, Standard of Care
- Keywords
- dialysis, sensipar, mimpara, hemodialysis, peritoneal dialysis, renal, parathyroid hormone, pediatric
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperparathyroidism, Hyperparathyroidism, Secondary, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cinacalcet capsuleDrug
Also called Sensipar, Mimpara
Cinacalcet was prepared for oral administration as both capsules for sprinkling and film coated tablets for swallowing.
placeboDrug
Placebo tablets and capsules for sprinkling identical to active treatment.
Standard of CareDrug
All participants, regardless of treatment assignment, will receive standard of care with vitamin D sterols (calcitriol and its analogs), as prescribed by the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg. Receives: Drug: placebo; Drug: Standard of Care |
| Cinacalcet | Experimental | Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Receives: Drug: cinacalcet capsule; Drug: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving ≥ 30% Reduction in Mean iPTH From Baseline to the Efficacy Assessment Phase
The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase (EAP; Weeks 25 - 30). When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available post-baseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.
Measured: From Baseline to the Efficacy Assessment Phase, Weeks 25-30
Secondary outcomes (7)
Percentage of Participants Achieving Mean iPTH ≤ 300 pg/mL (31.8 Pmol/L) During the Efficacy Assessment Phase
The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.
Measured: From Baseline to the Efficacy Assessment Phase (EAP), Weeks 25-30
Percent Change From Baseline in Mean Corrected Total Serum Calcium During the Efficacy Assessment Period
Serum calcium was reported as a corrected value by the central laboratory based on calcium and albumin concentrations: Corrected total calcium (mg/dL) = measured total serum calcium (mg/dL) + 0.8 (4.0 - Serum albumin (g/dL)). The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used."
Measured: From Baseline to the Efficacy Assessment Phase, Weeks 25-30.
Percent Change From Baseline in Mean Serum Phosphorus During the Efficacy Assessment Phase
The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.
Measured: From Baseline to the Efficacy Assessment Phase, Weeks 25-30.
Percent Change From Baseline in Mean Phosphorous Product (Ca x P) During the Efficacy Assessment Phase
The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.
Measured: From Baseline to end of Efficacy Assessment Period, assessed up to 30 weeks
Growth Velocity From Baseline to End of Double-blind Phase
Linear growth velocity (cm/year) = 52 x change in height (cm) / number of weeks between the two assessments. End of double-blind phase visit was at Week 30 by design but the last assessment in the double-blind phase was used due to the early termination of the study.
Measured: From Baseline to end of Efficacy Assessment at Week 30
Growth Velocity From End of Double-blind Phase to End of Open-label Phase
Linear growth velocity (cm/year) = 52 x change in height (cm) / number of weeks between the two assessments. End of open-label phase visit was at Week 60 by design but the last assessment in the open-label phase was used due to the early termination of the study.
Measured: End of double-blind phase (Week 30) until end of the open-label phase (Week 60)
Percent Change From Baseline in Mean Ionized Calcium During the Efficacy Assessment Phase
The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase. When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available postbaseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.
Measured: From Baseline to the Efficacy Assessment Phase, Weeks 25-30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study start28 Jun 2011
- Primary completion30 Apr 2014
Why it stopped: Study was put on clinical hold on 30 Jan 2013 following a subject fatality. Study was never restarted and was closed.
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 (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by AmgenThe 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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277510
- Sponsor's protocol ID
- 20070208
- Status last verified
- Jun 2020
- First submitted
- 13 Jan 2011
- Last updated
- 29 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Warady BA, Iles JN, Ariceta G, Dehmel B, Hidalgo G, Jiang X, Laskin B, Shahinfar S, Vande Walle J, Schaefer F. A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of cinacalcet in pediatric patients with chronic kidney disease and secondary hyperparathyroidism receiving dialysis. Pediatr Nephrol. 2019 Mar;34(3):475-486. doi: 10.1007/s00467-018-4116-y. Epub 2018 Nov 30.
PubMed 30506144Warady BA, Ng E, Bloss L, Mo M, Schaefer F, Bacchetta J. Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis. Pediatr Nephrol. 2020 Sep;35(9):1679-1697. doi: 10.1007/s00467-020-04516-4. Epub 2020 May 4.
PubMed 32367309
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of Cinacalcet HCl in Pediatric Subjects With Chronic Kidney Disease and Secondary Hyperparathyroidism Receiving Dialysis
- ClinicalTrials.gov ID
- NCT01277510
- Acronym / sponsor ID
- 20070208
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Hyperparathyroidism, Secondary, Kidney Disease, Secondary Hyperparathyroidism
- Keywords
- dialysis, sensipar, mimpara, hemodialysis, peritoneal dialysis, renal, parathyroid hormone, pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was put on clinical hold on 30 Jan 2013 following a subject fatality. Study was never restarted and was closed.
- Enrolment
- 43 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2011 (actual)
- Primary completion
- 30 Apr 2014 (actual)
- First posted
- 17 Jan 2011 (estimated)
- Results
- Posted 15 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and efficacy of adding cinacalcet to the current treatment of secondary hyperparathyroidism in children currently receiving dialysis compared to a treatment regimen that does not include cinacalcet.
Detailed description
Secondary hyperparathyroidism (SHPT) is a condition that can develop early in patients with chronic kidney disease (CKD), usually gets worse over time, and is known to cause problems for patients on dialysis. Children on dialysis can have a wide range of bone and growth issues, and common treatments have a chance of making these things worse by increasing serum calcium and serum phosphorus. Cinacalcet has been shown to be effective in controlling parathyroid hormone (PTH), calcium and phosphorus in adults. The purpose of this study is to show that including cinacalcet in the treatment of SHPT will lower the levels of intact parathyroid hormone (iPTH) in a larger number of pediatric patients with CKD who are receiving dialysis, compared to a treatment regimen that does not include cinacalcet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: placebo, Drug: Standard of CareParticipants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg. |
| Cinacalcet | Experimental | Drug: cinacalcet capsule, Drug: Standard of CareParticipants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Age 6 to less than 18 years at screening
- Diagnosed with CKD and SHPT receiving hemodialysis or peritoneal dialysis for ≥ 2 months before randomization
- Dry weight ≥ 12.5 kg at screening
- iPTH obtained from the central laboratory must be > 300 pg/mL (31.8 pmol/L)
- Serum calcium (corrected) obtained from the central laboratory must be ≥ 8.8 mg/dL (2.2 mmol/L)
Key exclusion criteria (5 listed)
- Underwent parathyroidectomy in the last 6 months
- Anticipated parathyroidectomy within 6 months after randomization
- Received therapy with cinacalcet (sensipar/mimpara) within the last month
- A new onset of seizure or worsening of a pre-existing seizure disorder within the last 3 months
- Scheduled date for kidney transplant from a known living donor that makes completion of the study unlikely
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 |
|---|---|---|
| cinacalcet capsuleAlso: Sensipar, MimparaCinacalcet was prepared for oral administration as both capsules for sprinkling and film coated tablets for swallowing. | Drug | Cinacalcet |
| placeboPlacebo tablets and capsules for sprinkling identical to active treatment. | Drug | Placebo |
| Standard of CareAll participants, regardless of treatment assignment, will receive standard of care with vitamin D sterols (calcitriol and its analogs), as prescribed by the treating physician. | Drug | Cinacalcet, Placebo |
Primary outcome
Percentage of Participants Achieving ≥ 30% Reduction in Mean iPTH From Baseline to the Efficacy Assessment Phase
Time frame: From Baseline to the Efficacy Assessment Phase, Weeks 25-30
The efficacy assessment value is based on the scheduled assessment(s) taken during the efficacy assessment phase (EAP; Weeks 25 - 30). When multiple assessments were available, the average of those was used. If an efficacy measurement during the EAP was missing, the mean of the last 2 available post-baseline values in the dose-titration phase was used. If only one post-baseline value was available, this single value was used.
7 secondary outcomes
Percentage of Participants Achieving Mean iPTH ≤ 300 pg/mL (31.8 Pmol/L) During the Efficacy Assessment Phase
Time frame: From Baseline to the Efficacy Assessment Phase (EAP), Weeks 25-30
Percent Change From Baseline in Mean Corrected Total Serum Calcium During the Efficacy Assessment Period
Time frame: From Baseline to the Efficacy Assessment Phase, Weeks 25-30.
Percent Change From Baseline in Mean Serum Phosphorus During the Efficacy Assessment Phase
Time frame: From Baseline to the Efficacy Assessment Phase, Weeks 25-30.
Percent Change From Baseline in Mean Phosphorous Product (Ca x P) During the Efficacy Assessment Phase
Time frame: From Baseline to end of Efficacy Assessment Period, assessed up to 30 weeks
Growth Velocity From Baseline to End of Double-blind Phase
Time frame: From Baseline to end of Efficacy Assessment at Week 30
Growth Velocity From End of Double-blind Phase to End of Open-label Phase
Time frame: End of double-blind phase (Week 30) until end of the open-label phase (Week 60)
Percent Change From Baseline in Mean Ionized Calcium During the Efficacy Assessment Phase
Time frame: From Baseline to the Efficacy Assessment Phase, Weeks 25-30.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30506144Warady BA, Iles JN, Ariceta G, Dehmel B, Hidalgo G, Jiang X, Laskin B, Shahinfar S, Vande Walle J, Schaefer F. A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of cinacalcet in pediatric patients with chronic kidney disease and secondary hyperparathyroidism receiving dialysis. Pediatr Nephrol. 2019 Mar;34(3):475-486. doi: 10.1007/s00467-018-4116-y. Epub 2018 Nov 30.
- Background: PubMed 32367309Warady BA, Ng E, Bloss L, Mo M, Schaefer F, Bacchetta J. Cinacalcet studies in pediatric subjects with secondary hyperparathyroidism receiving dialysis. Pediatr Nephrol. 2020 Sep;35(9):1679-1697. doi: 10.1007/s00467-020-04516-4. Epub 2020 May 4.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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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.
MD study director
Amgen
51 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cinacalcet capsule in people with Chronic Kidney Disease and Hyperparathyroidism, run by Amgen at 51 sites in 10 countries.
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 10 inclusion and 5 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: stopped early, as of the sponsor's last update on 29 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Spain, Poland, Australia, Belgium and 5 more countries. 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. Some participants in this study may receive a placebo. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 15 May 2015). 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?
Percentage of Participants Achieving ≥ 30% Reduction in Mean iPTH From Baseline to the Efficacy Assessment Phase (time frame: From Baseline to the Efficacy Assessment Phase, Weeks 25-30). 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 NCT01277510, which also lists 2 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 29 Jun 2020.