OsteoporosisPhase 2NCT00960934

A Dose-Ranging Study of MK-5442 in Postmenopausal Women With Osteoporosis (MK-5442-001)

A Phase 2 study testing MK-5442, Vitamin D3 and Calcium carbonate in people with Osteoporosis, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study was to identify an appropriate dose of MK-5442 that produced an osteoanabolic effect without causing hypercalcemia in postmenopausal women with osteoporosis. Read more about this study

Who is it for?: Ages 45 to 85 years, women only
Conditions the study is for: Osteoporosis
What is being tested?: MK-5442, Vitamin D3 and Calcium carbonate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 383 participants
Where: No sites listed yet
Study dates: Oct 2009to Dec 2010
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 45 to 85 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Postmenopausal for at least 5 years
No history of fragility fracture, unless participant is not willing to take marketed osteoporosis therapy or is not a candidate for marketed osteoporosis therapy
Agrees not to use medications for osteoporosis except medications associated with the study
Areal bone mineral density (BMD) T-score <-2.5 at one or more of the following 4 BMD sites: total hip, femoral neck, trochanter, or lumbar spine and is ≥ -3.5 at all 4 BMD sites. Participants unwilling to take or ineligible for marketed osteoporosis therapy may have one or more areal BMD T-scores of < -3.5

Who cannot join

Unable to undergo dual-energy X-ray absorptiometry (DXA) scan due to obesity (ie, weight >250 lbs)
Use of oral bisphosphonates in the 6 months prior to study screening, for more than 3 months in the past 2 years, or lifetime use of more than 6 months
Use of intravenous bisphosphonates, strontium, or growth hormone at any time
Use of phenytoin or heparin within 2 weeks prior to Visit 1; use of raloxifene within 6 months prior to Visit 1
Use of pioglitazone or rosiglitazone at study screening
Use of estrogen ± progestin, in any form other than vaginal or topical application, for 6 months prior to Study Visit 1

Show all 13Show fewer

Prior total thyroidectomy
Human immunodeficiency virus (HIV)- positive or acquired immune deficiency syndrome (AIDS)-related illness
History of malignant cancer within 5 years of study screening, except for certain skin or cervical cancers
History of Paget's disease and/or kidney stones
An active user of any illicit drug
History of or active alcohol abuse
Participated in an investigational drug study within the past 30 days

About this study

Official title: A Phase IIb, Randomized, Placebo-Controlled, Dose-Ranging Study of MK-5442 in the Treatment of Postmenopausal Women With Osteoporosis

The purpose of this study was to identify an appropriate dose of

MK-5442 that produced an osteoanabolic effect without causing hypercalcemia in postmenopausal women with osteoporosis.

Read the detailed description

Amendment 4 of the protocol changed the duration of the study from 2 years to 6 months.

Conditions: Osteoporosis
Being tested: MK-5442, Placebo, Vitamin D3, Calcium carbonate
Keywords: Osteoporosis, Postmenopausal, MK-5442
Medical subject headings: Osteoporosis

What participants receive

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

MK-5442Drug
MK-5442 2.5 mg, 5 mg, 7.5 mg, 10 mg, or 15 mg tablet once daily for at least 6 months.
PlaceboDrug
Dose-matched oral placebo to MK-5442
Vitamin D3Dietary supplement
Vitamin D3, two 400 IU tablets daily throughout the study.
Calcium carbonateDietary supplement
Participants who had a calcium intake of less than 1200 mg/day at baseline received a daily 500 mg calcium supplement throughout the study.

Study groups in NCT00960934
Study group	Role	What they receive
MK-5442 2.5 mg	Experimental	Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months. Receives: Drug: MK-5442; Drug: Placebo; Dietary Supplement: Vitamin D3; Dietary Supplement: Calcium carbonate
MK-5442 5 mg	Experimental	Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months. Receives: Drug: MK-5442; Drug: Placebo; Dietary Supplement: Vitamin D3; Dietary Supplement: Calcium carbonate
MK-5442 7.5 mg	Experimental	Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months. Receives: Drug: MK-5442; Drug: Placebo; Dietary Supplement: Vitamin D3; Dietary Supplement: Calcium carbonate
MK-5442 10 mg	Experimental	Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months. Receives: Drug: MK-5442; Drug: Placebo; Dietary Supplement: Vitamin D3; Dietary Supplement: Calcium carbonate
MK-5442 15 mg	Experimental	Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months. Receives: Drug: MK-5442; Drug: Placebo; Dietary Supplement: Vitamin D3; Dietary Supplement: Calcium carbonate
Placebo	Placebo comparator	Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months. Receives: Drug: Placebo; Dietary Supplement: Vitamin D3; Dietary Supplement: Calcium carbonate

What is being measured

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

Least Squares (LS) Mean Percent Change From Baseline to Month 6 in Lumbar Spine Areal Bone Mineral Density (aBMD)
Dual Energy X-ray Absorptiometry (DXA) was used to assess and measure aBMD of the lumbar spine. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2).
Measured: Baseline (BL) and Month 6
Percentage of Participants With Total Serum Calcium Levels Outside the Pre-defined Limits of Change
Normal serum calcium level is 8-10 mg/dL (2-2.5 mmol/L) with some interlaboratory variation in the reference range, and hypercalcemia is defined as a serum calcium level greater than 10.5 mg/dL (>2.5 mmol/L).
Based on these references, ≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with calcium levels ≥10.6 mg/dL were considered as having a "Tier 1" safety event.
Measured: Baseline through Month 6
Percentage of Participants With Albumin-Corrected Calcium Levels Outside the Pre-defined Limits of Change
Albumin-Corrected Calcium = ([4 - plasma albumin in g/dL] × 0.8 + serum calcium).
≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with albumin-corrected calcium levels ≥10.6 mg/dL were considered as having a "Tier 1" safety event.
Measured: Baseline through Month 6
Percentage of Participants With Kidney Stones
Evidence of kidney stone(s) was considered an event of interest and was prespecified as a "Tier 1" safety event.
Measured: Baseline through Month 6
Percentage of Participants With Bone Neoplasms
Evidence of bone neoplasm(s) was considered an event of interest and was prespecified as a "Tier 1" safety event.
Measured: Baseline through Month 6

Secondary outcomes (12)

LS Mean Percent Change From Baseline to Month 6 in Total Hip aBMD
DXA was used to assess and measure aBMD of the total hip. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2).
Measured: Baseline and Month 6
LS Mean Percent Change From Baseline to Month 6 in Femoral Neck aBMD
DXA was used to assess and measure aBMD of the femoral neck. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2).
Measured: Baseline and Month 6
LS Mean Percent Change From Baseline to Month 6 in Trochanter aBMD
DXA was used to assess and measure aBMD of the trochanter. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2).
Measured: Baseline and Month 6
LS Mean Percent Change From Baseline to Month 6 in Total Body aBMD
DXA was used to assess and measure aBMD of the total body. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2).
Measured: Baseline and Month 6
LS Mean Percent Change From Baseline to Month 6 in Distal One-third Forearm Areal BMD
DXA was used to assess and measure aBMD of the distal 1/3 forearm. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2).
Measured: Baseline and Month 6
LS Mean Percent Change From Baseline to Month 6 in Trabecular Volumetric BMD of the Hip
Quantitative computed tomography (QCT) technology was used to assess and measure bone mineral content volumetrically (ie, in grams of tissue per centimeter of tissue cubed).
Measured: Baseline and Month 6
LS Mean Percent Change From Baseline to Month 6 in Trabecular Volumetric BMD of the Lumbar Spine
Quantitative computed tomography (QCT) technology was used at baseline and periodically through out the study to assess and measure bone mineral content volumetrically (ie, in grams of tissue per centimeter of tissue cubed).
Measured: Baseline and Month 6
LS Mean Percent Change From Baseline to Month 6 in the Ratio of Urinary N-Telopeptides of Type I Collagen to Creatinine (u-NTx/Cr)
The ratio of u-NTx to Cr is a biomarker for bone resorption. It is measured in the serum in units of nanomoles (nm) of bone collagen equivalents (BCE)/millimoles of creatinine (Cr).
Measured: Baseline and Month 6
LS Mean Percent Change From Baseline to Month 6 in Serum C-Terminal Telopeptide Collagen I (s-CTx)
C-Terminal Telopeptide Collagen I is used as a serum-marker of bone resorption in the assessment of osteoporosis.
Measured: Baseline to Month 6
LS Mean Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (s-BSAP)
Bone Specific Alkaline Phosphatase is a biomarker of bone formation and is measured in units of microgram (μg)/liter (L).
Measured: Baseline and Month 6
LS Mean Percent Change From Baseline to Month 6 in Serum Procollagen Type I N-Terminal Propeptide (P1NP)
Measurement of P1NP appears to be a sensitive marker of bone formation rate in the assessment of osteoporosis.
Measured: Baseline to Month 6
LS Mean Percent Change From Baseline to Month 6 in Serum Osteocalcin
Serum osteocalcin is a biomarker of bone formation and is measured using units of nanograms (ng) / milliliter (mL).
Measured: Baseline and Month 6

Timeline

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

Oct 2009Dec 2010

First posted18 Aug 2009 (estimated)
Study startOct 2009
Primary completionDec 2010
Study completionDec 2010

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: 383 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00960934
Sponsor's protocol ID: 5442-001
Other IDs: 2009-012926-35, 2009
Status last verified: Feb 2015
First submitted: 17 Aug 2009
Last updated: 18 Feb 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Halse J, Greenspan S, Cosman F, Ellis G, Santora A, Leung A, Heyden N, Samanta S, Doleckyj S, Rosenberg E, Denker AE. A phase 2, randomized, placebo-controlled, dose-ranging study of the calcium-sensing receptor antagonist MK-5442 in the treatment of postmenopausal women with osteoporosis. J Clin Endocrinol Metab. 2014 Nov;99(11):E2207-15. doi: 10.1210/jc.2013-4009. Epub 2014 Aug 28.
PubMed 25166719

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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Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIb, Randomized, Placebo-Controlled, Dose-Ranging Study of MK-5442 in the Treatment of Postmenopausal Women With Osteoporosis
ClinicalTrials.gov ID: NCT00960934
Acronym / sponsor ID: 5442-001
Conditions: Osteoporosis
Keywords: Osteoporosis, Postmenopausal, MK-5442
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 383 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Oct 2009
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 18 Aug 2009 (estimated)
Results: Posted 10 Oct 2012

Clinical summary

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

The purpose of this study was to identify an appropriate dose of

MK-5442 that produced an osteoanabolic effect without causing hypercalcemia in postmenopausal women with osteoporosis.

Detailed description

Amendment 4 of the protocol changed the duration of the study from 2 years to 6 months.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
MK-5442 2.5 mg	Experimental	Drug: MK-5442, Drug: Placebo, Dietary Supplement: Vitamin D3, Dietary Supplement: Calcium carbonateFollowing a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
MK-5442 5 mg	Experimental	Drug: MK-5442, Drug: Placebo, Dietary Supplement: Vitamin D3, Dietary Supplement: Calcium carbonateFollowing a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
MK-5442 7.5 mg	Experimental	Drug: MK-5442, Drug: Placebo, Dietary Supplement: Vitamin D3, Dietary Supplement: Calcium carbonateFollowing a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
MK-5442 10 mg	Experimental	Drug: MK-5442, Drug: Placebo, Dietary Supplement: Vitamin D3, Dietary Supplement: Calcium carbonateFollowing a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
MK-5442 15 mg	Experimental	Drug: MK-5442, Drug: Placebo, Dietary Supplement: Vitamin D3, Dietary Supplement: Calcium carbonateFollowing a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
Placebo	Placebo comparator	Drug: Placebo, Dietary Supplement: Vitamin D3, Dietary Supplement: Calcium carbonateFollowing a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.

Who may qualify

Ages: 45 to 85 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Postmenopausal for at least 5 years
No history of fragility fracture, unless participant is not willing to take marketed osteoporosis therapy or is not a candidate for marketed osteoporosis therapy
Agrees not to use medications for osteoporosis except medications associated with the study
Areal bone mineral density (BMD) T-score <-2.5 at one or more of the following 4 BMD sites: total hip, femoral neck, trochanter, or lumbar spine and is ≥ -3.5 at all 4 BMD sites. Participants unwilling to take or ineligible for marketed osteoporosis therapy may have one or more areal BMD T-scores of < -3.5

Key exclusion criteria (13 listed)

Unable to undergo dual-energy X-ray absorptiometry (DXA) scan due to obesity (ie, weight >250 lbs)
Use of oral bisphosphonates in the 6 months prior to study screening, for more than 3 months in the past 2 years, or lifetime use of more than 6 months
Use of intravenous bisphosphonates, strontium, or growth hormone at any time
Use of phenytoin or heparin within 2 weeks prior to Visit 1; use of raloxifene within 6 months prior to Visit 1
Use of pioglitazone or rosiglitazone at study screening

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-5442MK-5442 2.5 mg, 5 mg, 7.5 mg, 10 mg, or 15 mg tablet once daily for at least 6 months.	Drug	MK-5442 10 mg, MK-5442 15 mg, MK-5442 2.5 mg, MK-5442 5 mg, MK-5442 7.5 mg
PlaceboDose-matched oral placebo to MK-5442	Drug	MK-5442 10 mg, MK-5442 15 mg, MK-5442 2.5 mg, MK-5442 5 mg, MK-5442 7.5 mg, Placebo
Vitamin D3Vitamin D3, two 400 IU tablets daily throughout the study.	Dietary supplement	MK-5442 10 mg, MK-5442 15 mg, MK-5442 2.5 mg, MK-5442 5 mg, MK-5442 7.5 mg, Placebo
Calcium carbonateParticipants who had a calcium intake of less than 1200 mg/day at baseline received a daily 500 mg calcium supplement throughout the study.	Dietary supplement	MK-5442 10 mg, MK-5442 15 mg, MK-5442 2.5 mg, MK-5442 5 mg, MK-5442 7.5 mg, Placebo

Primary outcome

Least Squares (LS) Mean Percent Change From Baseline to Month 6 in Lumbar Spine Areal Bone Mineral Density (aBMD)
Time frame: Baseline (BL) and Month 6
Dual Energy X-ray Absorptiometry (DXA) was used to assess and measure aBMD of the lumbar spine. Areal BMD was measured as "areal" density using units of gram (gm) of tissue /centimeter of tissue squared (cm^2).
Percentage of Participants With Total Serum Calcium Levels Outside the Pre-defined Limits of Change
Time frame: Baseline through Month 6
Normal serum calcium level is 8-10 mg/dL (2-2.5 mmol/L) with some interlaboratory variation in the reference range, and hypercalcemia is defined as a serum calcium level greater than 10.5 mg/dL (>2.5 mmol/L). Based on these references, ≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with calcium levels ≥10.6 mg/dL were considered as having a "Tier 1" safety event.
Percentage of Participants With Albumin-Corrected Calcium Levels Outside the Pre-defined Limits of Change
Time frame: Baseline through Month 6
Albumin-Corrected Calcium = ([4 - plasma albumin in g/dL] × 0.8 + serum calcium). ≥10.6 mg/dL was predefined in this study as the cut-off for the normal limits of change. Participants with albumin-corrected calcium levels ≥10.6 mg/dL were considered as having a "Tier 1" safety event.
Percentage of Participants With Kidney Stones
Time frame: Baseline through Month 6
Evidence of kidney stone(s) was considered an event of interest and was prespecified as a "Tier 1" safety event.
Percentage of Participants With Bone Neoplasms
Time frame: Baseline through Month 6
Evidence of bone neoplasm(s) was considered an event of interest and was prespecified as a "Tier 1" safety event.

12 secondary outcomes

LS Mean Percent Change From Baseline to Month 6 in Total Hip aBMD
Time frame: Baseline and Month 6
LS Mean Percent Change From Baseline to Month 6 in Femoral Neck aBMD
Time frame: Baseline and Month 6
LS Mean Percent Change From Baseline to Month 6 in Trochanter aBMD
Time frame: Baseline and Month 6
LS Mean Percent Change From Baseline to Month 6 in Total Body aBMD
Time frame: Baseline and Month 6
LS Mean Percent Change From Baseline to Month 6 in Distal One-third Forearm Areal BMD
Time frame: Baseline and Month 6
LS Mean Percent Change From Baseline to Month 6 in Trabecular Volumetric BMD of the Hip
Time frame: Baseline and Month 6
LS Mean Percent Change From Baseline to Month 6 in Trabecular Volumetric BMD of the Lumbar Spine
Time frame: Baseline and Month 6
LS Mean Percent Change From Baseline to Month 6 in the Ratio of Urinary N-Telopeptides of Type I Collagen to Creatinine (u-NTx/Cr)
Time frame: Baseline and Month 6
LS Mean Percent Change From Baseline to Month 6 in Serum C-Terminal Telopeptide Collagen I (s-CTx)
Time frame: Baseline to Month 6
LS Mean Percent Change From Baseline to Month 6 in Serum Bone-Specific Alkaline Phosphatase (s-BSAP)
Time frame: Baseline and Month 6
LS Mean Percent Change From Baseline to Month 6 in Serum Procollagen Type I N-Terminal Propeptide (P1NP)
Time frame: Baseline to Month 6
LS Mean Percent Change From Baseline to Month 6 in Serum Osteocalcin
Time frame: Baseline and Month 6

Results and safety

Results posted to the registry on 10 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MK-5442 2.5 mg	64	0
MK-5442 5 mg	63	0
MK-5442 7.5 mg	64	0
MK-5442 10 mg	64	0
MK-5442 15 mg	64	0
Placebo	64	0

Primary outcome: Least Squares (LS) Mean Percent Change From Baseline to Month 6 in Lumbar Spine Areal Bone Mineral Density (aBMD)

Time frame: Baseline (BL) and Month 6. Least squares mean (95% Confidence Interval). Unit: percent change

Measure	MK-5442 2.5 mg n = 58	MK-5442 5 mg n = 54	MK-5442 7.5 mg n = 56	MK-5442 10 mg n = 55	MK-5442 15 mg n = 56	Placebo n = 56
Value	0.74 (-0.21 to 1.68)	1.50 (0.53 to 2.48)	0.92 (-0.02 to 1.87)	1.69 (0.73 to 2.64)	1.13 (0.18 to 2.08)	0.57 (-0.40 to 1.55)

MK-5442 15 mg vs Placebo: LS Mean Difference in Change From BL: 0.56 (95% CI -1.04 to 2.16), p = 0.749, Longitudinal Data Analysis Model
MK-5442 10 mg vs Placebo: LS Mean Difference in Change From BL: 1.12 (95% CI -0.60 to 2.83), p = 0.333, Longitudinal Data Analysis Model
MK-5442 7.5 mg vs Placebo: LS Mean Difference in Change From BL: 0.35 (95% CI -1.14 to 1.84), p = 0.823, Longitudinal Data Analysis Model

Population analysed: Full Analysis Set (FAS); participants who received at least one dose of study treatment, had post-randomization data subsequent to at least one dose of study treatment, and who had baseline data.

Primary outcome: Percentage of Participants With Total Serum Calcium Levels Outside the Pre-defined Limits of Change

Time frame: Baseline through Month 6. Number. Unit: Percentage of participants

Measure	MK-5442 2.5 mg n = 64	MK-5442 5 mg n = 62	MK-5442 7.5 mg n = 64	MK-5442 10 mg n = 64	MK-5442 15 mg n = 63	Placebo n = 63
Value	7.8	32.3	32.8	56.3	73.0	3.2

MK-5442 15 mg vs Placebo: Mean Difference (Final Values): 69.8 (95% CI 56.5 to 80.0), p <0.001, Miettinen and Nurminen Method
MK-5442 10 mg vs Placebo: Mean Difference (Final Values): 53.1 (95% CI 39.6 to 65.2), p <0.001, Miettinen and Nurminen Method
MK-5442 7.5 mg vs Placebo: Mean Difference (Final Values): 29.6 (95% CI 17.6 to 42.4), p <0.001, Miettinen and Nurminen Method

Population analysed: All Participants as Treated (APaT) population; all randomized participants who received at least one dose of study treatment. 3 randomized participants did not receive treatment and were not included in the APaT.

Primary outcome: Percentage of Participants With Albumin-Corrected Calcium Levels Outside the Pre-defined Limits of Change

Time frame: Baseline through Month 6. Number. Unit: Percentage of participants

Measure	MK-5442 2.5 mg n = 64	MK-5442 5 mg n = 62	MK-5442 7.5 mg n = 64	MK-5442 10 mg n = 64	MK-5442 15 mg n = 63	Placebo n = 63
Value	0.0	9.7 (2.96 to 5.35)	18.8 (2.75 to 5.09)	37.5 (4.28 to 6.69)	49.2 (5.10 to 7.50)	1.6 (-1.04 to 1.22)

MK-5442 15 mg vs Placebo: Mean Difference (Final Values): 47.6 (95% CI 34.9 to 60.0), p <0.001, Miettinen and Nurminen Method
MK-5442 10 mg vs Placebo: Mean Difference (Final Values): 35.9 (95% CI 24.1 to 48.5), p <0.001, Miettinen and Nurminen Method
MK-5442 7.5 mg vs Placebo: Mean Difference (Final Values): 17.2 (95% CI 7.7 to 28.7), p = 0.001, Miettinen and Nurminen Method

Primary outcome: Percentage of Participants With Kidney Stones

Time frame: Baseline through Month 6. Number. Unit: Percentage of participants

Measure	MK-5442 2.5 mg n = 64	MK-5442 5 mg n = 62	MK-5442 7.5 mg n = 64	MK-5442 10 mg n = 64	MK-5442 15 mg n = 63	Placebo n = 63
Value	1.6	1.6	0.0	0.0	0.0	0.0

MK-5442 15 mg vs Placebo: Mean Difference (Final Values): 0.0 (95% CI -5.8 to 5.8), p >0.999, Miettinen and Nurminen Method
MK-5442 10 mg vs Placebo: Mean Difference (Final Values): 0 (95% CI -5.8 to 5.7), p >0.999, Miettinen and Nurminen Method
MK-5442 7.5 mg vs Placebo: Mean Difference (Final Values): 0.0 (95% CI -5.8 to 5.7), p >0.999, Miettinen and Nurminen Method

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: From October 2, 2009 to December 21, 2010, with an in-house data-cut date of February 10, 2011. Other adverse events reported at 0.05% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MK-5442 2.5 mg	3 of 64 (4.7%)	18 of 64 (28.1%)	Not reported
MK-5442 5 mg	0 of 62 (0%)	24 of 62 (38.7%)	Not reported
MK-5442 7.5 mg	4 of 64 (6.3%)	15 of 64 (23.4%)	Not reported
MK-5442 10 mg	5 of 64 (7.8%)	28 of 64 (43.8%)	Not reported
MK-5442 15 mg	4 of 63 (6.3%)	18 of 63 (28.6%)	Not reported
Placebo	3 of 63 (4.8%)	26 of 63 (41.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25166719Halse J, Greenspan S, Cosman F, Ellis G, Santora A, Leung A, Heyden N, Samanta S, Doleckyj S, Rosenberg E, Denker AE. A phase 2, randomized, placebo-controlled, dose-ranging study of the calcium-sensing receptor antagonist MK-5442 in the treatment of postmenopausal women with osteoporosis. J Clin Endocrinol Metab. 2014 Nov;99(11):E2207-15. doi: 10.1210/jc.2013-4009. Epub 2014 Aug 28.

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Active, not recruitingObservational study
The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women
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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.

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 2 study testing MK-5442, Vitamin D3 and Calcium carbonate 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 4 inclusion and 13 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: stopped early, as of the sponsor's last update on 18 Feb 2015. 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 10 Oct 2012). 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?

Least Squares (LS) Mean Percent Change From Baseline to Month 6 in Lumbar Spine Areal Bone Mineral Density (aBMD) (time frame: Baseline (BL) and Month 6). The study lists 5 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 NCT00960934, 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 18 Feb 2015.