Trial Outcomes & Findings for Safety and Efficacy of Alendronate (Fosamax) in Children With Osteoporosis (NCT NCT00259857)
NCT ID: NCT00259857
Last Updated: 2011-01-19
Results Overview
Participants were screened for BMD of lumbar spine using DXA scan at visit 12 months after alendronate or placebo treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
12 months therapy
Results posted on
2011-01-19
Participant Flow
Dates of recruitment period:O5/27/2004 to 02/01/2006. Types of location:outpatient clinic, Clinical and Translational Research Center (CTRC), Medical University of South Carolina, Charleston, South Carolina.
Participant milestones
| Measure |
Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D
Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
|
Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D
Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
|
|---|---|---|
|
12 Months Treatment
STARTED
|
11
|
11
|
|
12 Months Treatment
COMPLETED
|
10
|
9
|
|
12 Months Treatment
NOT COMPLETED
|
1
|
2
|
|
24 Months Treatment
STARTED
|
10
|
9
|
|
24 Months Treatment
COMPLETED
|
10
|
6
|
|
24 Months Treatment
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D
Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
|
Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D
Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
|
|---|---|---|
|
12 Months Treatment
Gr-1, lost followup; Gr-2, not compliant
|
1
|
2
|
|
24 Months Treatment
Lost to Follow-up
|
0
|
3
|
Baseline Characteristics
Safety and Efficacy of Alendronate (Fosamax) in Children With Osteoporosis
Baseline characteristics by cohort
| Measure |
Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D
n=11 Participants
Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
|
Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D
n=11 Participants
Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
9.17 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
9.47 years
STANDARD_DEVIATION 2.3 • n=7 Participants
|
9.32 years
STANDARD_DEVIATION 0.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months therapyPopulation: Analysis was done per protocol and intention to treat.
Participants were screened for BMD of lumbar spine using DXA scan at visit 12 months after alendronate or placebo treatment.
Outcome measures
| Measure |
Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D
n=10 Participants
Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
|
Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D
n=9 Participants
Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
|
|---|---|---|
|
Number of Participants With Improvement in Bone Mineral Density (BMD) of Spine After Therapy
|
10 participants
|
9 participants
|
PRIMARY outcome
Timeframe: 24 months therapyPopulation: Analysis was done per protocol and intention to treat.
BMD of lumbar spine was measured using DXA scan at visit 24 months (Year-2)after alendronate or placebo treatment.
Outcome measures
| Measure |
Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D
n=10 Participants
Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
|
Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D
n=6 Participants
Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
|
|---|---|---|
|
Number of Participants With Improvement in Bone Mineral Density (BMD) of Spine After Therapy
|
10 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 12 months of therapyPopulation: Analysis was done per protocol and intention to treat.
Outcome measures
| Measure |
Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D
n=10 Participants
Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
|
Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D
n=9 Participants
Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
|
|---|---|---|
|
Number of Participants With Improvement in Bone Mineral Density (BMD) of Hip After Therapy
|
10 participants
|
9 participants
|
SECONDARY outcome
Timeframe: 24 months of therapyPopulation: Analysis was done per protocol and intention to treat.
Analysis was done per protocol and intention to treat.
Outcome measures
| Measure |
Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D
n=10 Participants
Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
|
Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D
n=6 Participants
Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
|
|---|---|---|
|
Number of Participants With Improvement in BMD of Hip
|
10 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 0 monthsPopulation: Number of participants with fractures before therapy.
Number of Participants with Atraumatic fractures before therapy.
Outcome measures
| Measure |
Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D
n=11 Participants
Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
|
Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D
n=11 Participants
Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
|
|---|---|---|
|
Participants With Atraumatic Fractures
|
11 participants
|
11 participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Number of participants with fractures at study completion.
Number of participants with fractures at the completion of therapy.
Outcome measures
| Measure |
Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D
n=10 Participants
Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
|
Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D
n=6 Participants
Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
|
|---|---|---|
|
Participants With Atraumatic Fractures
|
0 participants
|
0 participants
|
Adverse Events
Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Deborah A Bowlby, MD, Asst.Professor, Pedeiatric Endocrinology
Medical University of South Carolina
Phone: 843-792-6807
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Agreement with Merck: to submit a copy of any proposed abstract, manuscript and/or press release to Merck for review and comment at least 30 days prior to submission for publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER