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OsteoporosisPhase 3NCT00692913

A Study to Test the Effect of MK0217A on Vitamin D Inadequacy in Postmenopausal Women With Osteoporosis (0217A-262)

A Phase 3 study testing FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol), Calcium Supplement 500 mg and Referred-Care Model 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
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Trial summary

A study designed to see if the study drug will increase blood levels of vitamin D, bone mineral density (BMD), improve biochemical markers of bone turnover, and reduce the number of falls as compared to women receiving standard care for osteoporosis. Read more about this study

Who is it for?
Ages 65 years and older, women only
Conditions the study is for
Osteoporosis
What is being tested?
FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol), Calcium Supplement 500 mg and Referred-Care Model
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
515 participants
Where
No sites listed yet
Study dates
Jun 2008to Jul 2010
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 65 years and older
  • Women only
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Female
  • 65 years or older
  • Diagnosed with osteoporosis (Bone Mineral Density (BMD) T-score <= -2.5 at spine or hip) or prior fragility fracture BMD T-score <=-1.5 in at least one of the anatomic sites including lumbar spine, total hip, and femoral neck sites
  • Postmenopausal
  • Low levels of vitamin D as measured 25-hydroxyvitamin D
  • Has fallen at least once within the past 12 months

Who cannot join

  • Unable to stand or sit upright for at least 30 minutes
  • Has a bone disorder other than osteoporosis
  • Contraindication to the use of FOSAVANCE

About this study

Official title: A Phase III (Phase V Program), Open-Label, Randomized, Referred-Care-Controlled, Clinical Trial to Evaluate the Efficacy and Safety of MK -0217A/Alendronate Sodium-70 mg/Vitamin D3 5600 I.U. Combination Tablet on Vitamin D Inadequacy in the Treatment of Osteoporosis in Postmenopausal Women

A study designed to see if the study drug will increase blood levels of vitamin D, bone mineral density (BMD), improve biochemical markers of bone turnover, and reduce the number of falls as compared to women receiving standard care for osteoporosis.

Conditions
Osteoporosis
Being tested
FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol), Calcium Supplement 500 mg, Referred-Care Model
Medical subject headings
Osteoporosis

What participants receive

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

  • FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol)Drug

    FOSAVANCE 5600 international units (IU)(Alendronate Sodium 70 mg/Vitamin D 5600 IU) combination tablet once weekly for 6 months (Week 26) during the base period and an additional 6-month extension period (Week 52).

  • Calcium Supplement 500 mgDietary supplement

    Calcium supplied locally by the investigator (containing 500 mg

    calcium supplement) daily for 52 weeks (unless the patient's dietary intake of

    calcium exceeds 1000 mg per day).

  • Referred-Care ModelOther

    Usual treatment for osteoporosis chosen and prescribed by patients' own physicians for 6 months (Week 26) during the base period and an additional 6-month extension period (Week 52).

Study groups in NCT00692913
Study groupRoleWhat they receive
FOSAVANCE 5600Experimentalalendronate sodium (+) cholecalciferol
Receives: Drug: FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol); Dietary Supplement: Calcium Supplement 500 mg
Referred-Care ModelOtherUsual treatment for osteoporosis chosen and prescribed by patients' own physicians.
Receives: Other: Referred-Care Model

What is being measured

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

  1. Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 26

    Percentage of participants with serum levels of 25-hydroxyvitamin D below

    20 nanograms/milliliter (ng/mL) after 26 weeks of treatment with FOSAVANCE 5600 once weekly versus Referred-Care in postmenopausal women with osteoporosis and at increased risk of falls.

    Measured: Week 26

Secondary outcomes (7)

  1. Percent Change From Baseline at Week 26 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio

    N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio (NTx) is a urine biochemical marker of bone resorption and measured in nanomoles (nmol) Bone Collagen Equivalents (BCE)/millimoles (mmol) creatinine. The percent change was calculated as: [100 * ((Week 26/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy.

    Measured: Baseline and Week 26

  2. Percent Change From Baseline at Week 26 in Bone-Specific Alkaline Phosphatase

    Bone-Specific Alkaline Phosphatase (BSAP) is a serum biochemical marker of bone formation and measured in micrograms/Liter (mcg/L). The percent change was calculated as: [100 * ((Week 26/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy.

    Measured: Baseline and Week 26

  3. Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 52

    Percentage of participants with serum levels of 25-hydroxyvitamin D below

    20 ng/mL after 52 weeks of treatment (6 month extension study) with FOSAVANCE 5600 once weekly versus Referred-Care in postmenopausal women with osteoporosis and at increased risk of falls.

    Measured: Week 52

  4. Percent Change From Baseline in Lumbar Spine and Total Hip Bone Mineral Density

    Bone Mineral Density (BMD) as measured by Dual Energy X-Ray Absorptiometry (DEXA) and measured in g/cm^2 was obtained at baseline (visit 1) and Week 52 (visit 13) or at early study discontinuation visit. The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent change from baseline, the greater the response to therapy.

    Measured: Baseline and Week 52

  5. Falls Per Participant

    Number of falls per participant was measured.

    The fall event rate during the study period was defined as the number of adjudicated falls during the study period divided by the total patient-years in the study. Each participant was to be in the study for approximately one year.

    In order to guide and standardize all procedures during the fall adjudication process, a Standard Operating Procedure for Fall Adjudication was created by the

    SPONSOR and served as a guideline to standardize operational procedures for fall adjudication.

    Measured: Up to Week 52

  6. Percent Change From Baseline at Week 52 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio

    NTx is a urine biochemical marker of bone resorption and measured in nanomoles (nmol) Bone Collagen Equivalents (BCE)/millimoles (mmol) creatinine. The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy.

    Measured: Baseline and Week 52

  7. Percent Change From Baseline at Week 52 in Bone-Specific Alkaline Phosphatase

    BSAP is a serum biochemical marker of bone formation and measured in micrograms/Liter (mcg/L). The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy.

    Measured: Baseline and Week 52

Timeline

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

  1. First posted6 Jun 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionJul 2010
  4. Study completionJul 2010

Resources

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
None (open label)
Enrolment
515 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00692913
Sponsor's protocol ID
0217A-262
Other IDs
2007_653
Status last verified
Feb 2022
First submitted
4 Jun 2008
Last updated
9 May 2024
Individual data sharing
No

Publications

  • Ralston SH, Binkley N, Boonen S, Kiel DP, Reginster JY, Roux C, Chen L, Rosenberg E, Santora A; FOCUS-D (FOSAVANCE vs. Standard Care-Use and Study of Vitamin D) Trial. Randomized trial of alendronate plus vitamin D3 versus standard care in osteoporotic postmenopausal women with vitamin D insufficiency. Calcif Tissue Int. 2011 Jun;88(6):485-94. doi: 10.1007/s00223-011-9482-4. Epub 2011 Apr 11.

    PubMed 21479913

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol), Calcium Supplement 500 mg and Referred-Care Model 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 6 inclusion and 3 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 9 May 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 15 Aug 2011). 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 With Serum Levels of 25-hydroxyvitamin D Below 20 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 NCT00692913, 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 9 May 2024.

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