AzTrials
AzTrials

Postmenopausal OsteoporosisPhase 3FACTNCT00092014

A Study to Evaluate and Compare Alendronate and Risedronate on Bone Mineral Density in Women With Postmenopausal Osteoporosis (MK-0217-211)

A Phase 3 study testing Alendronate, Risedronate 35 mg and Elemental Calcium in people with Postmenopausal 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 is to evaluate and compare the effects of Alendronate and Risedronate to treat women with postmenopausal osteoporosis. The primary hypothesis for this study is that in postmenopausal women with osteoporosis, treatment with oral alendronate 70 mg once weekly will produce a mean percent increase from baseline… Read more about this study

Who is it for?
Ages 25 years and older, women only
Conditions the study is for
Postmenopausal Osteoporosis
What is being tested?
Alendronate, Risedronate 35 mg and Elemental Calcium
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,053 participants
Where
No sites listed yet
Study dates
1 Sep 2002to 1 Apr 2004
Phase
Phase 3
Are there results?
None posted in the registry

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 25 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women with postmenopausal osteoporosis

Who cannot join

  • Bilateral hip replacements
  • Esophageal abnormalities
  • Metabolic bone disease (example - Vitamin D deficiency)
  • Medications that would affect the breakdown or build-up of bone turnover

About this study

Official title: A 12-Month Extension to: A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Multicenter Study to Evaluate and Compare the Effects of Once Weekly Alendronate and Risedronate on Bone Mineral Density in Postmenopausal Women With Osteoporosis

This study is to evaluate and compare the effects of Alendronate and Risedronate to treat women with postmenopausal osteoporosis. The primary hypothesis for this study is that in postmenopausal women with osteoporosis, treatment with oral alendronate 70 mg once weekly will produce a mean percent increase from baseline in hip trochanter bone mineral density (BMD) at 12 and 24 months which is greater than that observed with oral risedronate 35 mg once weekly.

Being tested
Alendronate, Risedronate 35 mg, Elemental Calcium, Vitamin D, Risendronate placebo
Medical subject headings
Osteoporosis, Postmenopausal

What participants receive

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

  • AlendronateDrug

    Also called MK-0217, FOSAMAX®

    Alendronate sodium, 70 mg, once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.

  • Risedronate 35 mgDrug

    Also called Actonel®, Atelvia®

    Risendronate, 35 mg, once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.

  • Elemental CalciumDietary supplement

    Elemental calcium at least 1,000 mg daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose.

  • Vitamin DDietary supplement

    Vitamin D at least 400 international units daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose.

  • Risendronate placeboDrug

    Risendronate placebo was taken once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.

  • Alendronate placeboDrug

    Alendronate placebo was taken once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.

Study groups in NCT00092014
Study groupRoleWhat they receive
Alendronate 70 mgExperimentalAlendronate sodium, 70 mg, orally once weekly for up to 24 months
Receives: Drug: Alendronate; Dietary Supplement: Elemental Calcium; Dietary Supplement: Vitamin D; Drug: Risendronate placebo
Risendronate 35 mgActive comparatorRisendronate, 35 mg, orally once weekly for up to 24 months
Receives: Drug: Risedronate 35 mg; Dietary Supplement: Elemental Calcium; Dietary Supplement: Vitamin D; Drug: Alendronate placebo

What is being measured

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

  1. Mean percent change from baseline in hip trochanter bone mineral density (BMD) at 12 months

    Measured: Baseline and 12 months

  2. Mean percent change from baseline in hip trochanter BMD at 24 months

    Measured: Baseline and 24 months

Secondary outcomes (8)

  1. Mean percent change from baseline in total hip, femoral neck, posteroanterior (PA) lumbar BMD at 12 months

    Measured: Baseline and 12 months

  2. Mean percent change from baseline in total hip, femoral neck, posteroanterior (PA) lumbar BMD at 24 months

    Measured: Baseline and 24 months

  3. Change from baseline in biochemical markers of bone turnover at 12 months

    Measured: Baseline and 12 months

  4. Change from baseline in biochemical markers of bone turnover at 24 months

    Measured: Baseline and 24 months

  5. Percent responders (>=0% and >=3% change from baseline in hip trochanter and lumbar spine BMD) at 12 months

    Measured: 12 months

  6. Percent responders ((>=0% and >=3% change from baseline in hip trochanter and lumbar spine BMD) at 24 months

    Measured: 24 months

  7. Number of participants who experienced one or more adverse events (AE)

    Measured: Up to 24 months

  8. Number of participants who discontinued study medication due to an AE

    Measured: Up to 24 months

Timeline

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

  1. First posted24 Sep 2004 (estimated)
  2. Study start1 Sep 2002
  3. Primary completion1 Apr 2004
  4. Study completion1 Apr 2004

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
Double blind
Who is masked
Participant, Investigator
Enrolment
1,053 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00092014
Sponsor's protocol ID
0217-211
Other IDs
2004_016
Acronym
FACT
Status last verified
Apr 2024
First submitted
21 Sep 2004
Last updated
14 Aug 2024
Results posted
No
Data monitoring committee
No

Publications

  • Rosen CJ, Hochberg MC, Bonnick SL, McClung M, Miller P, Broy S, Kagan R, Chen E, Petruschke RA, Thompson DE, de Papp AE; Fosamax Actonel Comparison Trial Investigators. Treatment with once-weekly alendronate 70 mg compared with once-weekly risedronate 35 mg in women with postmenopausal osteoporosis: a randomized double-blind study. J Bone Miner Res. 2005 Jan;20(1):141-51. doi: 10.1359/JBMR.040920. Epub 2004 Sep 29.

    PubMed 15619680

  • Sebba AI, Bonnick SL, Kagan R, Thompson DE, Skalky CS, Chen E, de Papp AE; Fosamax Actonel Comparison Trial investigators. Response to therapy with once-weekly alendronate 70 mg compared to once-weekly risedronate 35 mg in the treatment of postmenopausal osteoporosis. Curr Med Res Opin. 2004 Dec;20(12):2031-41. doi: 10.1185/030079904x16768.

    PubMed 15706659

  • Bonnick S, Saag KG, Kiel DP, McClung M, Hochberg M, Burnett SM, Sebba A, Kagan R, Chen E, Thompson DE, de Papp AE. Comparison of weekly treatment of postmenopausal osteoporosis with alendronate versus risedronate over two years. J Clin Endocrinol Metab. 2006 Jul;91(7):2631-7. doi: 10.1210/jc.2005-2602. Epub 2006 Apr 24.

    PubMed 16636120

  • Burnett-Bowie SM, Saag K, Sebba A, de Papp AE, Chen E, Rosenberg E, Greenspan SL. Prediction of changes in bone mineral density in postmenopausal women treated with once-weekly bisphosphonates. J Clin Endocrinol Metab. 2009 Apr;94(4):1097-103. doi: 10.1210/jc.2008-1122. Epub 2009 Jan 13.

    PubMed 19141590

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Alendronate, Risedronate 35 mg and Elemental Calcium in people with Postmenopausal 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 1 inclusion and 4 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 14 Aug 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Mean percent change from baseline in hip trochanter bone mineral density (BMD) at 12 months (time frame: Baseline and 12 months). The study lists 2 primary outcomes in all. 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 NCT00092014, which also lists 4 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 14 Aug 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in