Osteoporosis PostmenopausalPhase 4NCT00729651
Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263)
A Phase 4 study testing alendronate sodium (+) cholecalciferol, Comparator: Alendronate sodium (Fosamax) and Comparator: Calcium in people with Osteoporosis Postmenopausal, run by Organon and Co.
Trial summary
To demonstrate the efficacy/safety of Fosamax Plus D Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Osteoporosis Postmenopausal
- What is being tested?
- alendronate sodium (+) cholecalciferol, Comparator: Alendronate sodium (Fosamax) and Comparator: Calcium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 343 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2008to 10 Apr 2009
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient agrees to apply sunscreen and limit sunlight-exposure to 1 hour per day during the study
- Patient has been diagnosed with osteoporosis
- Patient has been postmenopausal for more than 6 months
- Patient has no contraindication to taking oral bisphosphonates
- Patient is eligible for dual energy x-ray absorptiometry in spine or hip
Who cannot join
- Patients with esophageal dysfunction
- Patients who can not sit or stand at least 30 minutes
- Patients who had a malignant disease or active systemic disease 5 years prior to participating in this trial
- Patients with diseases of bone or mineral metabolism besides osteoporosis or receiving therapies which affect bone metabolism or calcium metabolism
- Patients with history of major gastrointestinal disease (peptic ulcer, malabsorption, esophageal disease, gastritis, gastroduodenitis, etc.) within the last 6 months
About this study
Official title: A Prospective, Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy and Safety of Fosamax Plus D in Postmenopausal Osteoporotic Women
To demonstrate the efficacy/safety of Fosamax Plus D
- Conditions
- Osteoporosis Postmenopausal
- Being tested
- alendronate sodium (+) cholecalciferol, Comparator: Alendronate sodium (Fosamax), Comparator: Calcium
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alendronate sodium (+) cholecalciferolDrug
Also called Fosamax Plus D
Alendronate sodium/Cholecalciferol; tablet, once weekly, for 16 weeks
Comparator: Alendronate sodium (Fosamax)Drug
Alendronate sodium; tablet, once weekly, for 16 weeks
Comparator: CalciumDietary supplement
500 mg oral tablet calcium once daily, for 16 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Alendronate sodium/Cholecalciferol Receives: Drug: alendronate sodium (+) cholecalciferol; Dietary Supplement: Comparator: Calcium |
| 2 | Active comparator | Alendronate sodium Receives: Drug: Comparator: Alendronate sodium (Fosamax); Dietary Supplement: Comparator: Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment
Measured: 16 weeks
Secondary outcomes (1)
Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment
Measured: Baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2008 (estimated)
- Study start20 Mar 2008
- Primary completion10 Apr 2009
- Study completion10 Apr 2009
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 (1)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis PostmenopausalStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729651
- Sponsor's protocol ID
- 0217A-263
- Other IDs
- MK0217A-263, 2008_015
- Status last verified
- Feb 2022
- First submitted
- 5 Aug 2008
- Last updated
- 23 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kim KJ, Min YK, Koh JM, Chung YS, Kim KM, Byun DW, Kim IJ, Kim M, Kim SS, Min KW, Han KO, Park HM, Shin CS, Choi SH, Park JS, Chung DJ, Mok JO, Baek HS, Moon SH, Kim YS, Lim SK; VALUE study group. Efficacy and safety of weekly alendronate plus vitamin D(3) 5600 IU versus weekly alendronate alone in Korean osteoporotic women: 16-week randomized trial. Yonsei Med J. 2014 May;55(3):715-24. doi: 10.3349/ymj.2014.55.3.715. Epub 2014 Apr 1.
PubMed 24719139
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open-label, Active-controlled Study to Evaluate the Efficacy and Safety of Fosamax Plus D in Postmenopausal Osteoporotic Women
- ClinicalTrials.gov ID
- NCT00729651
- Acronym / sponsor ID
- 0217A-263
- Conditions
- Osteoporosis Postmenopausal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 343 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2008 (actual)
- Primary completion
- 10 Apr 2009 (actual)
- Study completion
- 10 Apr 2009 (actual)
- First posted
- 7 Aug 2008 (estimated)
- Results
- Posted 2 Apr 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate the efficacy/safety of Fosamax Plus D
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: alendronate sodium (+) cholecalciferol, Dietary Supplement: Comparator: CalciumAlendronate sodium/Cholecalciferol |
| 2 | Active comparator | Drug: Comparator: Alendronate sodium (Fosamax), Dietary Supplement: Comparator: CalciumAlendronate sodium |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient agrees to apply sunscreen and limit sunlight-exposure to 1 hour per day during the study
- Patient has been diagnosed with osteoporosis
- Patient has been postmenopausal for more than 6 months
- Patient has no contraindication to taking oral bisphosphonates
- Patient is eligible for dual energy x-ray absorptiometry in spine or hip
Key exclusion criteria (5 listed)
- Patients with esophageal dysfunction
- Patients who can not sit or stand at least 30 minutes
- Patients who had a malignant disease or active systemic disease 5 years prior to participating in this trial
- Patients with diseases of bone or mineral metabolism besides osteoporosis or receiving therapies which affect bone metabolism or calcium metabolism
- Patients with history of major gastrointestinal disease (peptic ulcer, malabsorption, esophageal disease, gastritis, gastroduodenitis, etc.) within the last 6 months
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 |
|---|---|---|
| alendronate sodium (+) cholecalciferolAlso: Fosamax Plus DAlendronate sodium/Cholecalciferol; tablet, once weekly, for 16 weeks | Drug | 1 |
| Comparator: Alendronate sodium (Fosamax)Alendronate sodium; tablet, once weekly, for 16 weeks | Drug | 2 |
| Comparator: Calcium500 mg oral tablet calcium once daily, for 16 weeks | Dietary supplement | 1, 2 |
Primary outcome
Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment
Time frame: 16 weeks
1 secondary outcome
Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment
Time frame: Baseline and 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24719139Kim KJ, Min YK, Koh JM, Chung YS, Kim KM, Byun DW, Kim IJ, Kim M, Kim SS, Min KW, Han KO, Park HM, Shin CS, Choi SH, Park JS, Chung DJ, Mok JO, Baek HS, Moon SH, Kim YS, Lim SK; VALUE study group. Efficacy and safety of weekly alendronate plus vitamin D(3) 5600 IU versus weekly alendronate alone in Korean osteoporotic women: 16-week randomized trial. Yonsei Med J. 2014 May;55(3):715-24. doi: 10.3349/ymj.2014.55.3.715. Epub 2014 Apr 1.
- Individual participant dataSharing planned: No
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing alendronate sodium (+) cholecalciferol, Comparator: Alendronate sodium (Fosamax) and Comparator: Calcium in people with Osteoporosis Postmenopausal, run by Organon and Co.
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 5 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: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 2 Apr 2010). 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?
Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment (time frame: 16 weeks). 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 NCT00729651, which also lists 1 linked publication.
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 23 Apr 2024.