OsteoporosisPhase 3NCT01437111

Study of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (MK-0217A-329)

A Phase 3 study testing MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet in people with Osteoporosis, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study will assess the effect of 26 weeks of once-weekly treatment with MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (Fosamax Plus 70/5600) on serum levels of 25-hydroxyvitamin D [25(OH)D]. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Osteoporosis
What is being tested?: MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: No sites listed yet
Study dates: 26 Oct 2011to 5 Dec 2012
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 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Man aged 50 or older, or a woman who is postmenopausal on day of signing informed consent or has been menopausal for at least one year
Meets bone mineral density (BMD) criteria
Agree to discontinue any osteoporosis drug treatment for duration of study

Who cannot join

Any contraindication to alendronate and vitamin D
Not ambulatory
Has received treatment with any anabolic steroid agent within the past 12 months, systemic glucocorticoids, for more than 2 weeks in the past 6 months, current use of immunosuppressants, fluoride treatment at a dose greater than 1 mg/day for more than 2 weeks within the past 3 months, treated with parathyroid hormone (PTH) for more than 2 weeks within the past 3 months, current use of chemotherapy or heparin, use of growth hormone for more than 2 weeks within the past 6 months, use of active hormonal vitamin D analogs in the past 2 months, current use of vitamin A >10,000 IU daily, current use of, lithium, or anti-convulsants including barbiturates, hydantoins, and carbamazepine, current use of calcium supplement in amount excess of 1500 mg daily, and/or current use of Vitamin D supplement
History of malignancy <5 years, except adequately treated basal cell or squamous cell skin cancer and in situ cervical cancer
One or more of the following concomitant conditions: Upper gastrointestinal (GI) disorders not adequately controlled; myocardial infarction, unstable angina, stroke and revascularization condition within 3 months; malabsorption syndrome; primary or secondary hyperparathyroidism not adequately treated; thyroid disease not adequately controlled; severe renal insufficiency; uncontrolled genitourinary, cardiovascular, hepatic, renal, endocrine, hematologic, neurological, psychiatric, or pulmonary diseases; uncontrolled hypertension; new onset diabetes (within 3 months), poorly controlled hyperglycemia, or hypoglycemia for any cause; evidence for metabolic bone disease other than osteoporosis; abnormal indices of calcium metabolism; and/or active renal stone disease
User of illicit recreational drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence
Heavy consumer of alcohol or alcohol containing products.

About this study

Official title: A Phase III (Phase IV Program) Open-Label, Multicenter Clinical Trial in Thailand to Study the Effect of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (Fosamax Plus 70/5600) for 6 Months on 25-Hydroxyvitamin D Levels in the Treatment of Osteoporosis in Postmenopausal Women and Men

Conditions: Osteoporosis
Being tested: MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet
Keywords: Osteoporosis, Postmenopausal
Medical subject headings: Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination TabletDrug
Also called Fosamax Plus 70/5600
One combination tablet orally once a week

Study groups in NCT01437111
Study group	Role	What they receive
Fosamax Plus	Experimental	Calcium supplement (elemental calcium and/or calcium carbonate) without vitamin D will also be supplied to participants Receives: Drug: MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26
Serum samples to measure serum 25-hydroxyvitamin D [25(OH)D] will be collected at specific visits during the treatment phase of the study.
Measured: Week 26

Secondary outcomes (1)

Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26
Serum samples for Beta-CrossLaps (β-CTx) will be collected at specific visits during the treatment phase of the study.
Measured: Baseline and Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Oct 20115 Dec 2012

First posted20 Sep 2011 (estimated)
Study start26 Oct 2011
Primary completion5 Dec 2012
Study completion5 Dec 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for OsteoporosisStudies 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 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01437111
Sponsor's protocol ID: 0217A-329
Status last verified: Feb 2022
First submitted: 19 Sep 2011
Last updated: 22 Apr 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Songpatanasilp T, Rojanasthien S, Sugkraroek P, Ongphiphadhanakul B, Robert L, Robert CS, Luevitoonvechkij S, Santora AC. Open-label study of treatment with alendronate sodium plus vitamin D in men and women with osteoporosis in Thailand. BMC Musculoskelet Disord. 2018 Nov 6;19(1):392. doi: 10.1186/s12891-018-2309-y.
PubMed 30400864

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis

All Osteoporosis trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III (Phase IV Program) Open-Label, Multicenter Clinical Trial in Thailand to Study the Effect of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (Fosamax Plus 70/5600) for 6 Months on 25-Hydroxyvitamin D Levels in the Treatment of Osteoporosis in Postmenopausal Women and Men
ClinicalTrials.gov ID: NCT01437111
Acronym / sponsor ID: 0217A-329
Conditions: Osteoporosis
Keywords: Osteoporosis, Postmenopausal
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: 26 Oct 2011 (actual)
Primary completion: 5 Dec 2012 (actual)
Study completion: 5 Dec 2012 (actual)
First posted: 20 Sep 2011 (estimated)
Results: Posted 22 Jan 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Fosamax Plus	Experimental	Drug: MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination TabletCalcium supplement (elemental calcium and/or calcium carbonate) without vitamin D will also be supplied to participants

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Man aged 50 or older, or a woman who is postmenopausal on day of signing informed consent or has been menopausal for at least one year
Meets bone mineral density (BMD) criteria
Agree to discontinue any osteoporosis drug treatment for duration of study

Key exclusion criteria (7 listed)

Any contraindication to alendronate and vitamin D
Not ambulatory
Has received treatment with any anabolic steroid agent within the past 12 months, systemic glucocorticoids, for more than 2 weeks in the past 6 months, current use of immunosuppressants, fluoride treatment at a dose greater than 1 mg/day for more than 2 weeks within the past 3 months, treated with parathyroid hormone (PTH) for more than 2 weeks within the past 3 months, current use of chemotherapy or heparin, use of growth hormone for more than 2 weeks within the past 6 months, use of active hormonal vitamin D analogs in the past 2 months, current use of vitamin A >10,000 IU daily, current use of, lithium, or anti-convulsants including barbiturates, hydantoins, and carbamazepine, current use of calcium supplement in amount excess of 1500 mg daily, and/or current use of Vitamin D supplement
History of malignancy <5 years, except adequately treated basal cell or squamous cell skin cancer and in situ cervical cancer
One or more of the following concomitant conditions: Upper gastrointestinal (GI) disorders not adequately controlled; myocardial infarction, unstable angina, stroke and revascularization condition within 3 months; malabsorption syndrome; primary or secondary hyperparathyroidism not adequately treated; thyroid disease not adequately controlled; severe renal insufficiency; uncontrolled genitourinary, cardiovascular, hepatic, renal, endocrine, hematologic, neurological, psychiatric, or pulmonary diseases; uncontrolled hypertension; new onset diabetes (within 3 months), poorly controlled hyperglycemia, or hypoglycemia for any cause; evidence for metabolic bone disease other than osteoporosis; abnormal indices of calcium metabolism; and/or active renal stone disease

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
MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination TabletAlso: Fosamax Plus 70/5600One combination tablet orally once a week	Drug	Fosamax Plus

Primary outcome

Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26
Time frame: Week 26
Serum samples to measure serum 25-hydroxyvitamin D [25(OH)D] will be collected at specific visits during the treatment phase of the study.

1 secondary outcome

Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26
Time frame: Baseline and Week 26

Results and safety

Results posted to the registry on 22 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fosamax Plus: All Participants	200	182

Primary outcome: Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26

Time frame: Week 26. Number. Unit: Participants

Measure	Fosamax Plus: Recent/Current Osteoporosis Therapy at Baseline n = 28	Fosamax Plus: Other Osteoporosis Therapy at Baseline n = 64	Fosamax Plus: Treatment Naive at Baseline n = 94	Fosamax Plus: All Treated Participants n = 186
Value	1	3	1	5

Population analysed: Full Analysis Set (FAS) consisted of participants who received \>=1 dose of study drug; had \>=1 post-baseline observation for the analysis endpoint; and had baseline data. For analysis, participants in the FAS were categorized into 3 subgroups by osteoporosis therapy received at baseline: Recent/Current, Other therapy, and Treatment Naïve

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to Week 26. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fosamax Plus: All Treated Participants	4 of 198 (2%)	10 of 198 (5.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30400864Songpatanasilp T, Rojanasthien S, Sugkraroek P, Ongphiphadhanakul B, Robert L, Robert CS, Luevitoonvechkij S, Santora AC. Open-label study of treatment with alendronate sodium plus vitamin D in men and women with osteoporosis in Thailand. BMC Musculoskelet Disord. 2018 Nov 6;19(1):392. doi: 10.1186/s12891-018-2309-y.
Individual participant dataSharing planned: No

Related trials for Osteoporosis

RecruitingObservational study
A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.
Vertebra Compression Fracture
Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
Osteosarcopenia, Sarcopenia
Active, not recruitingPhase 2
TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status
Pre-Frailty, Sarcopenia
Not yet recruitingPhase 4
Romosozumab and Denosumab Combination Therapy for Osteoporosis
Postmenopausal Osteoporosis
RecruitingObservational study
Assessment and Comparison of Osteoporosis Risk Factors After Stroke
Stroke, Osteoporosis

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet in people with Osteoporosis, 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 3 inclusion and 7 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 22 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 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 22 Jan 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?

Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26 (time frame: Week 26). 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 NCT01437111, 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 22 Apr 2024.