OsteoporosisPhase 2NCT00885170

A Study to Evaluate the Safety, Tolerability, and Efficacy of Odanacatib (MK-0822) in Postmenopausal Women Previously Treated With a Bisphosphonate (MK-0822-042)

A Phase 2 study testing Odanacatib, Vitamin D3 and Calcium in people with Osteoporosis, run by Merck Sharp & Dohme LLC.

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

Who is it for?: Ages 60 years and older, women only
Conditions the study is for: Osteoporosis
What is being tested?: Odanacatib, Vitamin D3 and Calcium
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 246 participants
Where: No sites listed yet
Study dates: 13 Apr 2009to 15 Sep 2011
Phase: Phase 2
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 60 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Has been postmenopausal for at least 5 years
Has taken or is taking alendronate
Agrees not to use medications for osteoporosis other than what is provided by the study

Who cannot join

Has a history or evidence of hip fracture
Has a history of cancer within 5 years of screening, except certain skin or cervical cancers.
Has active parathyroid disease
Has a history of thyroid disease not adequately controlled by medication
Is taking anti-seizure medication and has abnormal calcium metabolism
Has received any bisphosphonate other than alendronate for 20% of the last 3 years, or within 3 months of screening

About this study

Official title: A Phase IIa Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Overall Safety in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With Alendronate

The study will evaluate the both the efficacy of odanacatib on Bone Mineral Density (BMD) and the safety of odanacatib for postmenopausal osteoporosis in patients previously treated with alendronate. The primary hypothesis of the trial is that treatment with odanacatib 50 mg once weekly will increase bone mineral density at the femoral neck compared to placebo at the end of 24 months.

Conditions: Osteoporosis
Being tested: Odanacatib, Placebo, Vitamin D3, Calcium
Medical subject headings: Osteoporosis

What participants receive

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

OdanacatibDrug
Odanacatib 50 mg tablets once weekly for 24 months
PlaceboDrug
Placebo to odanacatib 50 mg tablets once weekly for 24 months
Vitamin D3Dietary supplement
Vitamin D3, two 2800 IU tablets, taken once weekly for 24 months
CalciumDietary supplement
Participants will receive calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.

Study groups in NCT00885170
Study group	Role	What they receive
Odanacatib 50 mg	Experimental	Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg. Receives: Drug: Odanacatib; Dietary Supplement: Vitamin D3; Dietary Supplement: Calcium
Placebo	Placebo comparator	Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg. Receives: Drug: Placebo; Dietary Supplement: Vitamin D3; Dietary Supplement: Calcium

What is being measured

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

Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Month 24
BMD at the femoral neck was assessed by dual-energy X-ray absorptiometry (DXA) at baseline and Month 24.
Measured: Baseline and Month 24
Percentage of Participants Experiencing One or More Adverse Events (AEs)
An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.
Measured: Up to 25 months
Percentage of Participants Discontinuing Study Drug Due to an AE
An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.
Measured: Up to 24 months

Secondary outcomes (22)

Percent Change From Baseline in Femoral Neck BMD at Month 12
BMD at the femoral neck was assessed by DXA at baseline and Month 12.
Measured: Baseline and 12 Months
Percent Change From Baseline in Trochanter BMD at Month 24
BMD at the trochanter was assessed by DXA at baseline and Month 24.
Measured: Baseline and 24 Months
Percent Change From Baseline in Trochanter BMD at Month 12
BMD at the trochanter was assessed by DXA at baseline and Month 12.
Measured: Baseline and 12 Months
Percent Change From Baseline in Total Hip BMD at Month 24
BMD at the total hip was assessed by DXA at baseline and Month 24.
Measured: Baseline and 24 Months
Percent Change From Baseline in Total Hip BMD at Month 12
BMD at the total hip was assessed by DXA at baseline and Month 12.
Measured: Baseline and 12 Months
Percent Change From Baseline in Lumbar Spine BMD at Month 24
BMD at the lumbar spine was assessed by DXA at baseline and Month 24.
Measured: Baseline and 24 Months
Percent Change From Baseline in Lumbar Spine BMD at Month 12
BMD at the lumbar spine was assessed by DXA at baseline and Month 12.
Measured: Baseline and 12 Months
Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 24
BMD at the 1/3 distal forearm was assessed by DXA at baseline and Month 24.
Measured: Baseline and 24 Months
Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 12
BMD at the 1/3 distal forearm was assessed by DXA at baseline and Month 12.
Measured: Baseline and 12 Months
Percent Change From Baseline in Log-Transformed Serum C-Telopeptides of Type I Collagen (s-CTx) at Month 24
s-CTx is a biochemical marker of bone resorption.
Measured: Baseline and Month 24
Percent Change From Baseline in Log-Transformed s-CTx at Month 12
s-CTx is a biochemical marker of bone resorption.
Measured: Baseline and Month 12
Percent Change From Baseline in Log-Transformed Urine N-Telopeptides/Creatinine Ratio at Month 24
N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio (u-NTx/Cr) is a biochemical marker of bone resorption.
Measured: Baseline and Month 24
Percent Change From Baseline in Log-Transformed u-NTx/Cr at Month 12
u-NTx/Cr is a biochemical marker of bone resorption.
Measured: Baseline and Month 12
Percent Change From Baseline in Log-Transformed Serum Bone-Specific Alkaline Phosphatase at Month 24
Bone-Specific Alkaline Phosphatase (BSAP) is a biochemical marker of bone formation.
Measured: Baseline and Month 24
Percent Change From Baseline in Log-Transformed Serum BSAP at Month 12
BSAP is a biochemical marker of bone formation.
Measured: Baseline and Month 12
Percent Change From Baseline in Log-Transformed Serum N-Terminal Propeptide of Type I Collagen at Month 24
Serum N-terminal propeptide of Type I collagen (s-P1NP) is a biochemical marker of bone formation.
Measured: Baseline and Month 24
Percent Change From Baseline in Log-Transformed Serum N-terminal Propeptide of Type I Collagen at Month 12
s-P1NP is a biochemical marker of bone formation.
Measured: Baseline and Month 12
Percent Change From Baseline in Log-Transformed Serum Calcium at Month 24
Serum calcium is an index of calcium homeostasis.
Measured: Baseline and Month 24
Percent Change From Baseline in Log-Transformed Serum Phosphate at Month 24
Serum phosphate is an index of mineral homeostasis.
Measured: Baseline and Month 24
Percent Change From Baseline in Log-Transformed Serum Parathyroid Hormone at Month 24
Serum parathyroid hormone (SPH) regulates calcium, phosphorus, and vitamin D levels in the blood.
Measured: Baseline and Month 24
Percent Change From Baseline in Log-Transformed Serum 1,25 Dihydroxyvitamin D at Month 24
1,25 dihydroxyvitamin D [1,25(OH)2 D] is the active vitamin D metabolite and stimulates calcium absorption in the intestine.
Measured: Baseline and Month 24
Percent Change From Baseline in Log-Transformed Serum 25-Hydroxyvitamin D at Month 24
The 25-hydroxy vitamin D [25(OH)D] test is the most accurate way to measure vitamin D. In the kidney, 25-hydroxy vitamin D is converted into 1,25 di-hydroxyvitamin D, the active vitamin D metabolite.
Measured: Baseline and Month 24

Timeline

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

13 Apr 200915 Sep 2011

First posted21 Apr 2009 (estimated)
Study start13 Apr 2009
Primary completion15 Sep 2011
Study completion15 Sep 2011

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.
More trials run by Merck Sharp & Dohme LLCThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 246 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00885170
Sponsor's protocol ID: 0822-042
Other IDs: 2009_578, CTRI/2009/091/000218, 2008-008257-30, 2008
Status last verified: Jul 2018
First submitted: 20 Apr 2009
Last updated: 28 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Bonnick S, De Villiers T, Odio A, Palacios S, Chapurlat R, DaSilva C, Scott BB, Le Bailly De Tilleghem C, Leung AT, Gurner D. Effects of odanacatib on BMD and safety in the treatment of osteoporosis in postmenopausal women previously treated with alendronate: a randomized placebo-controlled trial. J Clin Endocrinol Metab. 2013 Dec;98(12):4727-35. doi: 10.1210/jc.2013-2020. Epub 2013 Sep 24.
PubMed 24064689

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

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All Osteoporosis trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIa Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Effects of Odanacatib (MK-0822) on Bone Mineral Density (BMD) and Overall Safety in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With Alendronate
ClinicalTrials.gov ID: NCT00885170
Acronym / sponsor ID: 0822-042
Conditions: Osteoporosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 246 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 13 Apr 2009 (actual)
Primary completion: 15 Sep 2011 (actual)
Study completion: 15 Sep 2011 (actual)
First posted: 21 Apr 2009 (estimated)
Results: Posted 18 Apr 2017

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: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Odanacatib 50 mg	Experimental	Drug: Odanacatib, Dietary Supplement: Vitamin D3, Dietary Supplement: CalciumOdanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.
Placebo	Placebo comparator	Drug: Placebo, Dietary Supplement: Vitamin D3, Dietary Supplement: CalciumPlacebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.

Who may qualify

Ages: 60 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Has been postmenopausal for at least 5 years
Has taken or is taking alendronate
Agrees not to use medications for osteoporosis other than what is provided by the study

Key exclusion criteria (6 listed)

Has a history or evidence of hip fracture
Has a history of cancer within 5 years of screening, except certain skin or cervical cancers.
Has active parathyroid disease
Has a history of thyroid disease not adequately controlled by medication
Is taking anti-seizure medication and has abnormal calcium metabolism

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
OdanacatibOdanacatib 50 mg tablets once weekly for 24 months	Drug	Odanacatib 50 mg
PlaceboPlacebo to odanacatib 50 mg tablets once weekly for 24 months	Drug	Placebo
Vitamin D3Vitamin D3, two 2800 IU tablets, taken once weekly for 24 months	Dietary supplement	Odanacatib 50 mg, Placebo
CalciumParticipants will receive calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.	Dietary supplement	Odanacatib 50 mg, Placebo

Primary outcome

Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Month 24
Time frame: Baseline and Month 24
BMD at the femoral neck was assessed by dual-energy X-ray absorptiometry (DXA) at baseline and Month 24.
Percentage of Participants Experiencing One or More Adverse Events (AEs)
Time frame: Up to 25 months
An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.
Percentage of Participants Discontinuing Study Drug Due to an AE
Time frame: Up to 24 months
An AE was defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it was considered related to the medical treatment or procedure, that occurred during the course of the study.

22 secondary outcomes

Percent Change From Baseline in Femoral Neck BMD at Month 12
Time frame: Baseline and 12 Months
Percent Change From Baseline in Trochanter BMD at Month 24
Time frame: Baseline and 24 Months
Percent Change From Baseline in Trochanter BMD at Month 12
Time frame: Baseline and 12 Months
Percent Change From Baseline in Total Hip BMD at Month 24
Time frame: Baseline and 24 Months
Percent Change From Baseline in Total Hip BMD at Month 12
Time frame: Baseline and 12 Months
Percent Change From Baseline in Lumbar Spine BMD at Month 24
Time frame: Baseline and 24 Months
Percent Change From Baseline in Lumbar Spine BMD at Month 12
Time frame: Baseline and 12 Months
Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 24
Time frame: Baseline and 24 Months
Percent Change From Baseline in 1/3 Distal Forearm BMD at Month 12
Time frame: Baseline and 12 Months
Percent Change From Baseline in Log-Transformed Serum C-Telopeptides of Type I Collagen (s-CTx) at Month 24
Time frame: Baseline and Month 24
Percent Change From Baseline in Log-Transformed s-CTx at Month 12
Time frame: Baseline and Month 12
Percent Change From Baseline in Log-Transformed Urine N-Telopeptides/Creatinine Ratio at Month 24
Time frame: Baseline and Month 24
Percent Change From Baseline in Log-Transformed u-NTx/Cr at Month 12
Time frame: Baseline and Month 12
Percent Change From Baseline in Log-Transformed Serum Bone-Specific Alkaline Phosphatase at Month 24
Time frame: Baseline and Month 24
Percent Change From Baseline in Log-Transformed Serum BSAP at Month 12
Time frame: Baseline and Month 12
Percent Change From Baseline in Log-Transformed Serum N-Terminal Propeptide of Type I Collagen at Month 24
Time frame: Baseline and Month 24
Percent Change From Baseline in Log-Transformed Serum N-terminal Propeptide of Type I Collagen at Month 12
Time frame: Baseline and Month 12
Percent Change From Baseline in Log-Transformed Serum Calcium at Month 24
Time frame: Baseline and Month 24
Percent Change From Baseline in Log-Transformed Serum Phosphate at Month 24
Time frame: Baseline and Month 24
Percent Change From Baseline in Log-Transformed Serum Parathyroid Hormone at Month 24
Time frame: Baseline and Month 24
Percent Change From Baseline in Log-Transformed Serum 1,25 Dihydroxyvitamin D at Month 24
Time frame: Baseline and Month 24
Percent Change From Baseline in Log-Transformed Serum 25-Hydroxyvitamin D at Month 24
Time frame: Baseline and Month 24

Results and safety

Results posted to the registry on 18 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Odanacatib 50 mg	124	86
Placebo	122	99

Primary outcome: Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Month 24

Time frame: Baseline and Month 24. Least squares mean (95% Confidence Interval). Unit: Percent Change

Measure	Odanacatib 50 mg n = 83	Placebo n = 95
Value	1.73 (0.61 to 2.85)	-0.94 (-1.98 to 0.10)

Odanacatib 50 mg vs Placebo: Difference in the Least Squares Means: 2.67 (95% CI 1.17 to 4.17), p <0.001, Constrained longitudinal data analysis

Population analysed: The population analyzed included all randomized, treated participants who had femoral neck BMD data at Baseline and Month 24.

Primary outcome: Percentage of Participants Experiencing One or More Adverse Events (AEs)

Time frame: Up to 25 months. Number. Unit: Percentage of participants

Measure	Odanacatib 50 mg n = 122	Placebo n = 121
Value	68.0	73.6

Odanacatib 50 mg vs Placebo: Difference in Percentages vs. Placebo: -5.5 (95% CI -16.9 to 6.0)

Population analysed: The population analyzed included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.

Primary outcome: Percentage of Participants Discontinuing Study Drug Due to an AE

Time frame: Up to 24 months. Number. Unit: Percentage of participants

Measure	Odanacatib 50 mg n = 122	Placebo n = 121
Value	9.0	3.3

Odanacatib 50 mg vs Placebo: Difference in the Percentage vs. Placebo: 5.7 (95% CI -0.4 to 12.6)

Population analysed: The population analyzed included all participants who took at least one dose of study medication and were counted in the treatment group of the medication they actually took.

22 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 25 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Odanacatib 50 mg	20 of 122 (16.4%)	40 of 122 (32.8%)	Not reported
Placebo	20 of 121 (16.5%)	48 of 121 (39.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24064689Bonnick S, De Villiers T, Odio A, Palacios S, Chapurlat R, DaSilva C, Scott BB, Le Bailly De Tilleghem C, Leung AT, Gurner D. Effects of odanacatib on BMD and safety in the treatment of osteoporosis in postmenopausal women previously treated with alendronate: a randomized placebo-controlled trial. J Clin Endocrinol Metab. 2013 Dec;98(12):4727-35. doi: 10.1210/jc.2013-2020. Epub 2013 Sep 24.
Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Related trials for Osteoporosis

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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 2 study testing Odanacatib, Vitamin D3 and Calcium in people with Osteoporosis, run by Merck Sharp & Dohme LLC.

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 6 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 28 Aug 2018. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 18 Apr 2017). 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?

Percent Change From Baseline in Femoral Neck Bone Mineral Density (BMD) at Month 24 (time frame: Baseline and Month 24). The study lists 3 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 NCT00885170, 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 28 Aug 2018.