Secondary HyperparathyroidismPhase 2BONAFIDENCT00261950
Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease
A Phase 2 study testing Sensipar (Cinacalcet HCl) in people with Secondary Hyperparathyroidism, run by Amgen at 55 sites in 12 countries.
Trial summary
The purpose of this study is to evaluate the effects of cinacalcet on markers of bone turnover in patients with kidney disease who are receiving dialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Hyperparathyroidism
- What is being tested?
- Sensipar (Cinacalcet HCl)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 55 sitesin 12 countries
- Study dates
- May 2006to May 2011
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Subjects will be eligible for the study if they meet all of the following criteria:
- One Intact Parathyroid Hormone (iPTH) determination obtained from the central laboratory must be >/= 300 pg/mL.
- One serum calcium determination obtained from the central laboratory must be >/= 8.4 mg/dL (2.1 mmol/L).
- One Bone Alkaline Phosphatase (BALP) determination obtained from the central laboratory must be >/= 20.9 ng/mL.
- Positive histologic confirmation of high bone turnover disease as assessed by the central bone histology center.
- Treated with dialysis >/= 1 month before the date of informed consent.
Exclusion Criteria: Subjects will be ineligible for the study if they:
- Have an unstable medical condition in the judgment of the investigator.
- Are pregnant or nursing women.
- Had a parathyroidectomy in the 3 months before the date of informed consent.
- For subjects prescribed vitamin D, have received vitamin D therapy for less than 30 days before day 1 or required a change in vitamin D brand or dose level within 30 days before day 1.
- Ever received therapy with Sensipar®/Mimpara®
Trial locations and contacts
55 sites in 12 countries.
55 sites in 12 countries
United States16 sites
Research Site
Allentown, Pennsylvania, 18103
Research Site
Baltimore, Maryland, 21205
Research Site
Denver, Colorado, 80220
Research Site
Evanston, Illinois, 60201
Research Site
Flushing, New York, 11355
Research Site
Fort Lauderdale, Florida, 33334
Research Site
Great Neck, New York, 11021
Research Site
Houston, Texas, 77076
Research Site
Los Angeles, California, 90095
Research Site
New Haven, Connecticut, 06511
Research Site
New Orleans, Louisiana, 70121
Research Site
New York, New York, 10032
Research Site
Phoenix, Arizona, 85012
Research Site
St Louis, Missouri, 63110
Research Site
Teaneck, New Jersey, 07666
Research Site
The Bronx, New York, 10467
Italy9 sites
Research Site
Avellino, 83100
Research Site
Cremona, 26100
Research Site
Genova, 16132
Research Site
Milan, 20162
Research Site
Ortona CH, 66026
Research Site
Ostia RM, 00122
Research Site
Roma, 00149
Research Site
Roma, 00184
Research Site
Roma (RM), 00133
Portugal6 sites
Research Site
Almada, 2800-455
Research Site
Estoril, 2765-294
Research Site
Guimarães, 4810-273
Research Site
Porto, PR, 4250-499
Research Site
Porto, 4200-072
Research Site
Vila Franca de Xira, 2600-076
Belgium5 sites
Research Site
Antwerp, 2020
Research Site
Antwerp, 2060
Research Site
Brussels, 1070
Research Site
Leuven, 3000
Research Site
Liège, 4000
Hungary5 sites
Research Site
Budapest, 1083
Research Site
Debrecen, 4012
Research Site
Győr, 9023
Research Site
Miskolc, 3526
Research Site
Nyíregyháza, 4400
Spain5 sites
Research Site
Alcorcón, Madrid, 28922
Research Site
Barcelona, Cataluña, 08003
Research Site
Barcelona, Cataluña, 08036
Research Site
Madrid, Madrid, 28046
Research Site
Santander, Cantabria, 39008
Poland3 sites
Research Site
Krakow, 31-501
Research Site
Lodz, 90-153
Research Site
Wroclaw, 50-556
Czechia2 sites
Research Site
Hradec Králové, 500 05
Research Site
Prague, 169 00
About this study
Official title: Bone Histomorphometry Assessment For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease
The purpose of this study is to evaluate the effects of cinacalcet on markers of bone turnover in patients with kidney disease who are receiving dialysis.
Read the detailed description
Secondary hyperparathyroidism (HPT) is common in people with end stage renal disease (kidney disease). Patients with secondary HPT often have enlarged parathyroid glands in the neck and as a result often have elevated parathyroid hormone (PTH) levels . Patients with secondary HPT may have bone disease (osteodystrophy). Cinacalcet has been used to decrease PTH levels in patients with secondary HPT. Patients with secondary HPT may have bone disease (osteodystrophy). This bone disease may cause bone pain, fractures, and poor formation of red blood cells. The purpose of this study is to evaluate effects of cinacalcet on markers of bone turnover in patients with kidney disease who are receiving dialysis.
- Conditions
- Secondary Hyperparathyroidism
- Being tested
- Sensipar (Cinacalcet HCl)
- Keywords
- Cinacalcet HCl, Cinacalcet, Amgen (AMG) 073, Sensipar, Mimpara, Calcimimetic
- Medical subject headings
- Hyperparathyroidism, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensipar (Cinacalcet HCl)Drug
All enrolled subjects receive study medication at a starting dose of 30 mg cinacalcet once daily beginning on day 1. Possible sequential doses are 30 mg, 60mg, 90mg, 120mg, 180 mg taken once daily. During the study, dose adjustment (dose increase/decrease/withholding) is based upon iPTH, serum calcium, and subject safety information. Subjects swallowed tablets whole without biting or chewing. Subjects were dispensed investigational product every 4 weeks starting from Day 1 through to Week 48.
| Study group | Role | What they receive |
|---|---|---|
| Cinacalcet | Experimental | All subjects were enrolled into the single arm to receive Cinacalcet. There was no comparator arm. Receives: Drug: Sensipar (Cinacalcet HCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to End of Study in Bone Formation Rate (BFR)
Measured: Baseline to week 52
Secondary outcomes (12)
Percent Change From Baseline in Serum Calcium During the Efficacy Assessment Phase (EAP)
Measured: Baseline to weeks 40-52
Percent Change From Baseline in Serum Phosphorus During the Efficacy Assessment Phase (EAP)
Measured: Baseline to weeks 40-52
Percent Change From Baseline in Ca x P During the Efficacy Assessment Phase (EAP)
Measured: Baseline to weeks 40-52
Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BALP) at Week 52
Measured: Baseline to week 52
Percent Change From Baseline in N - Telopeptide (NTx) at Week 52
Measured: Baseline to week 52
Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Assessment Phase (EAP)
Measured: Baseline to weeks 40-52
Change From Baseline to End of Study in Osteoblast Perimeter (Osteoblast Perimeter/Osteoid Perimeter)
Osteoblast Perimeter was calculated as "Osteoblast Perimeter/Osteoid Perimeter * 100"
Measured: Baseline to week 52
Change From Baseline to End of Study in Osteoclast Perimeter (Osteoclast Perimeter/Eroded Perimeter)
Osteoclast Perimeter was calculated as "Osteoclast Perimeter/Eroded Perimeter * 100"
Measured: Baseline to week 52
Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area
Categorisation at each timepoint was based on fibrosis area as a percentage of tissue area (Fibrosis Area/Tissue Area * 100)
Measured: Baseline to week 52
Change From Baseline to End of Study in Eroded Perimeter/Bone Perimeter
Eroded Perimeter/Bone Perimeter was calculated as "Eroded Perimeter/Bone Perimeter * 100"
Measured: Baseline to week 52
Percent Change From Baseline in Osteocalcin (OC) at Week 52
Measured: Baseline to week 52
Percent Change From Baseline in Tartrate Resistant Acid Phosphatase(TRAP) at Week 52
Measured: Baseline to week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2005 (estimated)
- Study startMay 2006
- Primary completionMay 2011
- Study completionMay 2011
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 Secondary HyperparathyroidismStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 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
- NCT00261950
- Sponsor's protocol ID
- 20050104
- Other IDs
- BONAFIDE Study, IND #56,010
- Acronym
- BONAFIDE
- Status last verified
- Jun 2014
- First submitted
- 2 Dec 2005
- Last updated
- 21 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
TBD.BONAFIDE Baseline/Primary Results.Journal-004521;
Behets GJ, Spasovski G, Sterling LR, Goodman WG, Spiegel DM, De Broe ME, D'Haese PC. Bone histomorphometry before and after long-term treatment with cinacalcet in dialysis patients with secondary hyperparathyroidism. Kidney Int. 2015 Apr;87(4):846-56. doi: 10.1038/ki.2014.349. Epub 2014 Oct 22.
PubMed 25337774
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Histomorphometry Assessment For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease
- ClinicalTrials.gov ID
- NCT00261950
- Acronym / sponsor ID
- BONAFIDE / 20050104
- Conditions
- Secondary Hyperparathyroidism
- Keywords
- Cinacalcet HCl, Cinacalcet, Amgen (AMG) 073, Sensipar, Mimpara, Calcimimetic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 6 Dec 2005 (estimated)
- Results
- Posted 4 Dec 2013
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 evaluate the effects of cinacalcet on markers of bone turnover in patients with kidney disease who are receiving dialysis.
Detailed description
Secondary hyperparathyroidism (HPT) is common in people with end stage renal disease (kidney disease). Patients with secondary HPT often have enlarged parathyroid glands in the neck and as a result often have elevated parathyroid hormone (PTH) levels . Patients with secondary HPT may have bone disease (osteodystrophy). Cinacalcet has been used to decrease PTH levels in patients with secondary HPT. Patients with secondary HPT may have bone disease (osteodystrophy). This bone disease may cause bone pain, fractures, and poor formation of red blood cells. The purpose of this study is to evaluate effects of cinacalcet on markers of bone turnover in patients with kidney disease who are receiving dialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cinacalcet | Experimental | Drug: Sensipar (Cinacalcet HCl)All subjects were enrolled into the single arm to receive Cinacalcet. There was no comparator arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Sensipar (Cinacalcet HCl)All enrolled subjects receive study medication at a starting dose of 30 mg cinacalcet once daily beginning on day 1. Possible sequential doses are 30 mg, 60mg, 90mg, 120mg, 180 mg taken once daily. During the study, dose adjustment (dose increase/decrease/withholding) is based upon iPTH, serum calcium, and subject safety information. Subjects swallowed tablets whole without biting or chewing. Subjects were dispensed investigational product every 4 weeks starting from Day 1 through to Week 48. | Drug | Cinacalcet |
Primary outcome
Change From Baseline to End of Study in Bone Formation Rate (BFR)
Time frame: Baseline to week 52
12 secondary outcomes
Percent Change From Baseline in Serum Calcium During the Efficacy Assessment Phase (EAP)
Time frame: Baseline to weeks 40-52
Percent Change From Baseline in Serum Phosphorus During the Efficacy Assessment Phase (EAP)
Time frame: Baseline to weeks 40-52
Percent Change From Baseline in Ca x P During the Efficacy Assessment Phase (EAP)
Time frame: Baseline to weeks 40-52
Percent Change From Baseline in Bone Specific Alkaline Phosphatase (BALP) at Week 52
Time frame: Baseline to week 52
Percent Change From Baseline in N - Telopeptide (NTx) at Week 52
Time frame: Baseline to week 52
Percent Change From Baseline in Parathyroid Hormone (PTH) During the Efficacy Assessment Phase (EAP)
Time frame: Baseline to weeks 40-52
Change From Baseline to End of Study in Osteoblast Perimeter (Osteoblast Perimeter/Osteoid Perimeter)
Time frame: Baseline to week 52
Change From Baseline to End of Study in Osteoclast Perimeter (Osteoclast Perimeter/Eroded Perimeter)
Time frame: Baseline to week 52
Change in Categorization From Baseline to End of Study in Fibrosis Area/Tissue Area
Time frame: Baseline to week 52
Change From Baseline to End of Study in Eroded Perimeter/Bone Perimeter
Time frame: Baseline to week 52
Percent Change From Baseline in Osteocalcin (OC) at Week 52
Time frame: Baseline to week 52
Percent Change From Baseline in Tartrate Resistant Acid Phosphatase(TRAP) at Week 52
Time frame: Baseline to week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundTBD.BONAFIDE Baseline/Primary Results.Journal-004521;
- Background: PubMed 25337774Behets GJ, Spasovski G, Sterling LR, Goodman WG, Spiegel DM, De Broe ME, D'Haese PC. Bone histomorphometry before and after long-term treatment with cinacalcet in dialysis patients with secondary hyperparathyroidism. Kidney Int. 2015 Apr;87(4):846-56. doi: 10.1038/ki.2014.349. Epub 2014 Oct 22.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
Related trials for Secondary Hyperparathyroidism
Enrolling by invitationObservational study
Strategies for Proactive Health in People With Kidney Function Decline
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A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism
Not yet recruitingObservational study
Osteoporosis & Renal Disease: Research in Primary Health Care Services
Osteoporosis, Chronic Kidney Disease Mineral and Bone Disorder
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The CPH-MBD Cohort
Chronic Kidney Disease Mineral and Bone Disorder, Chronic Kidney Disease (CKD)
Not yet recruitingObservational study
Hyperparathyroidism and Dialysis Adequacy in Hemodialysis Patients
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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
55 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sensipar (Cinacalcet HCl) in people with Secondary Hyperparathyroidism, run by Amgen at 55 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 21 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United States, Italy, Portugal, Belgium, Hungary and 7 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 4 Dec 2013). 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?
Change From Baseline to End of Study in Bone Formation Rate (BFR) (time frame: Baseline to week 52). 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 NCT00261950, 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 21 Jul 2014.