Paget's Disease of the BonePhase 4NCT00668200
Impact on Reducing the Incidence of Low Serum Calcium by Providing Educational Materials on the Need to Take Daily Supplemental Calcium and Vitamin D to Patients With Paget's Disease Treated With Reclast®
A Phase 4 study testing Reclast (ZOL446, zoledronic acid), Calcium and Vitamin D in people with Paget's Disease of the Bone and Hypocalcemia, run by Novartis Pharmaceuticals at 9 sites in United States.
Trial summary
This study will evaluate the impact of investigator and patient education and educational materials to foster calcium and vitamin D supplementation to mitigate the potential for hypocalcemia post Reclast® administration in patients with Paget's disease of bone. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Paget's Disease of the Bone, Hypocalcemia
- What is being tested?
- Reclast (ZOL446, zoledronic acid), Calcium and Vitamin D
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 9 sitesUnited States
- Study dates
- May 2008to Nov 2012
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written informed consent
- As per currently approved Reclast® Package Insert:
Who cannot join
- As per currently approved Reclast® Package Insert:
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Novartis Investigative Site
Dallas, Texas, 75216
Novartis Investigative Site
Detroit, Michigan, 48236
Novartis Investigative Site
Gainesville, Georgia, 30501
Novartis Investigative Site
Madison, Wisconsin, 53705-3611
Novartis Investigative Site
Phoenix, Arizona, 85012
Novartis Investigative Site
Providence, Rhode Island, 02908
Novartis Investigative Site
Syracuse, New York, 13210-2306
Novartis Investigative Site
Tucson, Arizona, 85723-0001
Novartis Investigative Site
Waco, Texas, 76708
About this study
Official title: Post US Approval Voluntary Registry Study to Determine Incidence of Hypocalcemia Post Reclast® Treatment in Patients With Paget's Disease After Institution of Educational Strategies to Improve Adherence to Calcium and Vitamin D Supplementation
This study will evaluate the impact of investigator and patient education and educational materials to foster calcium and vitamin D supplementation to mitigate the potential for hypocalcemia post Reclast® administration in patients with Paget's disease of bone.
- Conditions
- Paget's Disease of the Bone, Hypocalcemia
- Being tested
- Reclast (ZOL446, zoledronic acid), Calcium, Vitamin D
- Keywords
- Paget's, hypocalcemia, zoledronic acid, serum calcium
- Medical subject headings
- Osteitis Deformans, Hypocalcemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reclast (ZOL446, zoledronic acid)Drug
Also called Reclast, ZOL446
5 mg i.v. annually ("real-life, physician prescribed")
CalciumDietary supplement
1500 mg elemental calcium daily in divided doses (the divided doses were 2-3 times per day depending on the formulation)
Vitamin DDietary supplement
800 IU vitamin D daily, particularly in the immediate 2 weeks following zoledronic acid administration
| Study group | Role | What they receive |
|---|---|---|
| zoledronic acid | Other | 5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate. Receives: Drug: Reclast (ZOL446, zoledronic acid); Dietary Supplement: Calcium; Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Serum Calcium <2.07 mmol/L at 9-11 Days After Receiving Zoledronic Acid.
To be included in the analysis, patients were required to have a baseline serum calcium of at least 2.07 mmol/L and at least one serum calcium measurement 9-11 days post-infusion of zoledronic acid. In case of multiple assessments, for baseline visit the last measurement prior to the first dose was used in the analysis, and for Visits 2 and 3, the lowest serum calcium in the visit window was used. hypocalcemia was defined as treatment-emergent serum calcium <2.07 mmol/L at 9-11 days after the study drug infusion.
Measured: at Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30)
Secondary outcomes (2)
Change From Baseline in Serum Calcium (mmol/L) - Safety Population
Change from baseline = endpoint - baseline, at each time point, only participants with a value at baseline and that time point are included in the change from baseline column. In case of multiple assessments, for baseline visit the last measurement prior to the first dose was used in the analysis, and for Visits 2 and 3, the lowest serum calcium in the visit window was used.
Measured: Baseline, Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30)
Percentage of Newly Occurring Post-baseline Hypocalcemia Symptoms Based on Hypocalcemia Questionnaire at End of Study Visit 2 or Visit 3 (Safety Population)
The end of study is not a separate time point. It is the last post-baseline, for majority the end of study was visit 2. There were 2 patients who had the end of study at Visit 3. If calcium at visit 2 was abnormal it was measured again at visit 3.
Measured: End of study: Visit 2 (days 9 - 11 post-infusion) or visit 3 (day 30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionNov 2012
- Study completionNov 2012
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.
- Other trials for Paget's Disease of the BoneStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00668200
- Sponsor's protocol ID
- CZOL446K2401
- Status last verified
- Feb 2015
- First submitted
- 22 Apr 2008
- Last updated
- 6 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post US Approval Voluntary Registry Study to Determine Incidence of Hypocalcemia Post Reclast® Treatment in Patients With Paget's Disease After Institution of Educational Strategies to Improve Adherence to Calcium and Vitamin D Supplementation
- ClinicalTrials.gov ID
- NCT00668200
- Acronym / sponsor ID
- CZOL446K2401
- Conditions
- Paget's Disease of the Bone, Hypocalcemia
- Keywords
- Paget's, hypocalcemia, zoledronic acid, serum calcium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 29 Apr 2008 (estimated)
- Results
- Posted 3 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the impact of investigator and patient education and educational materials to foster calcium and vitamin D supplementation to mitigate the potential for hypocalcemia post Reclast® administration in patients with Paget's disease of bone.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| zoledronic acid | Other | Drug: Reclast (ZOL446, zoledronic acid), Dietary Supplement: Calcium, Dietary Supplement: Vitamin D5 mg of Reclast (ZOL446, zoledronic acid) injection in 100 mL ready to infuse solution administered intravenously via a vented line. The infusion time was to be not less than 15 minutes given over a constant infusion rate. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Written informed consent
- As per currently approved Reclast® Package Insert:
Key exclusion criteria (1 listed)
- As per currently approved Reclast® Package Insert:
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 |
|---|---|---|
| Reclast (ZOL446, zoledronic acid)Also: Reclast, ZOL4465 mg i.v. annually ("real-life, physician prescribed") | Drug | zoledronic acid |
| Calcium1500 mg elemental calcium daily in divided doses (the divided doses were 2-3 times per day depending on the formulation) | Dietary supplement | zoledronic acid |
| Vitamin D800 IU vitamin D daily, particularly in the immediate 2 weeks following zoledronic acid administration | Dietary supplement | zoledronic acid |
Primary outcome
Percentage of Patients With Serum Calcium <2.07 mmol/L at 9-11 Days After Receiving Zoledronic Acid.
Time frame: at Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30)
To be included in the analysis, patients were required to have a baseline serum calcium of at least 2.07 mmol/L and at least one serum calcium measurement 9-11 days post-infusion of zoledronic acid. In case of multiple assessments, for baseline visit the last measurement prior to the first dose was used in the analysis, and for Visits 2 and 3, the lowest serum calcium in the visit window was used. hypocalcemia was defined as treatment-emergent serum calcium <2.07 mmol/L at 9-11 days after the study drug infusion.
2 secondary outcomes
Change From Baseline in Serum Calcium (mmol/L) - Safety Population
Time frame: Baseline, Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30)
Percentage of Newly Occurring Post-baseline Hypocalcemia Symptoms Based on Hypocalcemia Questionnaire at End of Study Visit 2 or Visit 3 (Safety Population)
Time frame: End of study: Visit 2 (days 9 - 11 post-infusion) or visit 3 (day 30)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
Related trials for Paget's Disease of the Bone
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingObservational study
Genetic Analysis to Predict the Development of Paget's Disease
Paget Disease, Paget Disease of Bone
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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Reclast (ZOL446, zoledronic acid), Calcium and Vitamin D in people with Paget's Disease of the Bone and Hypocalcemia, run by Novartis Pharmaceuticals at 9 sites 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 2 inclusion and 1 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 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 3 Mar 2014). 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 Patients With Serum Calcium <2.07 mmol/L at 9-11 Days After Receiving Zoledronic Acid. (time frame: at Visit 2 (days 9 - 11 post-infusion), visit 3 (day 30)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Mar 2015.