Trial Outcomes & Findings for A Study to Evaluate Alendronate Sodium /Vitamin D3 Combination Tablets(FOSAMAX PLUS) Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China (MK-0217A-264) (NCT NCT01350934)
NCT ID: NCT01350934
Last Updated: 2024-06-20
Results Overview
BMD at the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA) at baseline and Month 6.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
219 participants
Primary outcome timeframe
Baseline and Month 6
Results posted on
2024-06-20
Participant Flow
Participant milestones
| Measure |
Fosamax Plus
Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
|
Calcitriol
Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
|
|---|---|---|
|
Base Study
STARTED
|
111
|
108
|
|
Base Study
COMPLETED
|
100
|
105
|
|
Base Study
NOT COMPLETED
|
11
|
3
|
|
Extension Study
STARTED
|
100
|
105
|
|
Extension Study
COMPLETED
|
95
|
101
|
|
Extension Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Fosamax Plus
Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
|
Calcitriol
Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
|
|---|---|---|
|
Base Study
Adverse Event
|
6
|
0
|
|
Base Study
Lost to Follow-up
|
1
|
0
|
|
Base Study
Protocol Violation
|
1
|
1
|
|
Base Study
Withdrawal by Subject
|
1
|
2
|
|
Base Study
Non-Compliance With Study Drug
|
2
|
0
|
|
Extension Study
Adverse Event
|
2
|
1
|
|
Extension Study
Lost to Follow-up
|
2
|
0
|
|
Extension Study
Protocol Violation
|
1
|
1
|
|
Extension Study
Lack of Efficacy
|
0
|
1
|
|
Extension Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
A Study to Evaluate Alendronate Sodium /Vitamin D3 Combination Tablets(FOSAMAX PLUS) Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China (MK-0217A-264)
Baseline characteristics by cohort
| Measure |
Fosamax Plus
n=101 Participants
Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
|
Calcitriol
n=107 Participants
Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
|
Total
n=208 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.6 Years
STANDARD_DEVIATION 7.97 • n=5 Participants
|
64.8 Years
STANDARD_DEVIATION 7.44 • n=7 Participants
|
65.2 Years
STANDARD_DEVIATION 7.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
101 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Month 6Population: Full Analysis Set (FAS) population, which consisted of all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for analyses that required baseline data.
BMD at the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA) at baseline and Month 6.
Outcome measures
| Measure |
Fosamax Plus
n=101 Participants
Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
|
Calcitriol
n=107 Participants
Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
|
|---|---|---|
|
Base Study: Percentage Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 6
|
3.54 Percent change
95% Confidence Interval 0.1070 • Interval 2.7 to 4.4
|
1.59 Percent change
95% Confidence Interval 0.1101 • Interval 0.8 to 2.4
|
PRIMARY outcome
Timeframe: Baseline and Month 12Population: Full Analysis Set (FAS) population, which consisted of all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for analyses that required baseline data.
BMD at the lumbar spine was assessed by DXA at baseline and Month 12.
Outcome measures
| Measure |
Fosamax Plus
n=97 Participants
Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
|
Calcitriol
n=104 Participants
Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
|
|---|---|---|
|
Extension Study: Percentage Change From Baseline in Lumbar Spine BMD at Month 12
|
5.17 Percent change
95% Confidence Interval 4.3 to 6.0 • Interval 4.3 to 6.0
|
2.26 Percent change
95% Confidence Interval 1.4 to 3.1 • Interval 1.4 to 3.1
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: Per-Protocol Set (PPS) population, which consisted of participants who received one dose of study treatment, had baseline measurement and had a Month 6 observation for the analysis endpoint, but excluded participants with at least one major protocol deviation.
s-P1NP is a biochemical marker of bone turnover that is particularly useful in monitoring bone resorption, a process by which bone is broken down within the body. s-P1NP was measured at baseline and Month 6.
Outcome measures
| Measure |
Fosamax Plus
n=98 Participants
Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
|
Calcitriol
n=105 Participants
Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
|
|---|---|---|
|
Base Study: Percentage Change From Baseline in Serum Procollagen Type 1 N-Terminal Propeptide (s-P1NP) at Month 6
|
-59.12 Percent change
Interval -62.03 to -55.98
|
-16.75 Percent change
Interval -22.53 to -10.54
|
SECONDARY outcome
Timeframe: Baseline and Month 6Population: Per-Protocol Set (PPS) population, which consisted of participants who received one dose of study treatment, had baseline measurement and had a Month 6 observation for the analysis endpoint, but excluded participants with at least one major protocol deviation.
s-CTx is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. s-CTx was measured at baseline and Month 6.
Outcome measures
| Measure |
Fosamax Plus
n=98 Participants
Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
|
Calcitriol
n=105 Participants
Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
|
|---|---|---|
|
Base Study: Percentage Change From Baseline in Serum C-Telopeptides of Type 1 Collagen (s-CTx) at Month 6
|
-79.23 Percent change
Interval -81.4 to -76.81
|
-27.20 Percent change
Interval -34.58 to -18.99
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Per-Protocol Set (PPS) population, which consisted of participants who received one dose of study treatment, had baseline measurement and had a Month 12 observation for the analysis endpoint, but excluded participants with at least one major protocol deviation.
s-P1NP is a biochemical marker of bone turnover that is particularly useful in monitoring bone resorption, a process by which bone is broken down within the body. s-P1NP was measured at baseline and Month 12.
Outcome measures
| Measure |
Fosamax Plus
n=93 Participants
Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
|
Calcitriol
n=103 Participants
Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
|
|---|---|---|
|
Extension Study: Percentage Change From Baseline in s-P1NP at Month 12
|
-68.07 Percent change
Interval -70.77 to -65.11
|
-17.00 Percent change
Interval -23.79 to -9.6
|
SECONDARY outcome
Timeframe: Baseline and Month 12Population: Per-Protocol Set (PPS) population, which consisted of participants who received one dose of study treatment, had baseline measurement and had a Month 12 observation for the analysis endpoint, but excluded participants with at least one major protocol deviation.
s-CTx is a biochemical marker for bone turnover that has been shown to detect increased bone resorption, a process by which bone is broken down within the body. s-CTx was measured at baseline and Month 12.
Outcome measures
| Measure |
Fosamax Plus
n=93 Participants
Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
|
Calcitriol
n=103 Participants
Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
|
|---|---|---|
|
Extension Study: Percentage Change From Baseline in s-CTx at Month 12
|
-76.15 Percent change
Interval -78.56 to -73.47
|
-24.19 Percent change
Interval -31.58 to -16.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and Month 12Population: Full Analysis Set (FAS) population, which consisted of all randomized participants who received at least one dose of study treatment, had at least one post-randomization observation for the analysis endpoint subsequent to at least one dose of study treatment, and had baseline data for analyses that required baseline data.
The term "vitamin D insufficiency" is used to describe vitamin D levels that are low enough to cause secondary hyperparathyroidism, bone loss, and increased risk of skeletal fracture. In this study, a threshold for vitamin D insufficiency was a level of serum 25(OH) D \<20 ng/mL.
Outcome measures
| Measure |
Fosamax Plus
n=99 Participants
Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
|
Calcitriol
n=105 Participants
Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
|
|---|---|---|
|
Extension Study: Percentage of Participants With Serum 25-Hydroxyvitamin (OH) D <20 ng/mL at Month 12
|
4.1 Percentage of Participants
|
47.1 Percentage of Participants
|
Adverse Events
Fosamax Plus
Serious events: 4 serious events
Other events: 39 other events
Deaths: 0 deaths
Calcitriol
Serious events: 5 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fosamax Plus
n=107 participants at risk
Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
|
Calcitriol
n=108 participants at risk
Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/107 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
0.93%
1/108 • Number of events 1 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Cellulitis
|
0.93%
1/107 • Number of events 1 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/108 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/107 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
1.9%
2/108 • Number of events 2 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/107 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
0.93%
1/108 • Number of events 1 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/107 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
0.93%
1/108 • Number of events 1 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.93%
1/107 • Number of events 1 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/108 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/107 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
0.93%
1/108 • Number of events 1 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Cerebral infarction
|
0.93%
1/107 • Number of events 1 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/108 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.93%
1/107 • Number of events 1 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
0.00%
0/108 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
Other adverse events
| Measure |
Fosamax Plus
n=107 participants at risk
Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
|
Calcitriol
n=108 participants at risk
Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.4%
9/107 • Number of events 11 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
2.8%
3/108 • Number of events 3 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.7%
4/107 • Number of events 8 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
5.6%
6/108 • Number of events 7 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
10.3%
11/107 • Number of events 17 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
12.0%
13/108 • Number of events 18 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.5%
7/107 • Number of events 7 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
5.6%
6/108 • Number of events 7 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
|
Investigations
Urine calcium increased
|
8.4%
9/107 • Number of events 10 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
11.1%
12/108 • Number of events 15 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/107 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
5.6%
6/108 • Number of events 6 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.5%
7/107 • Number of events 14 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
4.6%
5/108 • Number of events 6 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
6/107 • Number of events 12 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
2.8%
3/108 • Number of events 3 • Up to Month 12
Safety analyses for this study were performed on the all patients as treated (APaT) population, which consisted of all randomized participants who received at least one dose of study treatment.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharpe & Dohme Corp
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER