Trial Outcomes & Findings for Phase II Study of Alendronate Sodium in Children With High-Turnover Idiopathic Juvenile Osteoporosis (NCT NCT00010439)

Results Overview

Number of participants with increase in bone mineral density at Lumbar Spine and/or Hip at 12 months as compared to the bone mineral density at Lumbar Spine and/or Hip obtained before therapy (baseline values)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

at 12 months

Results posted on

2010-11-08

Participant Flow

Dates of the recruitment period: 5/3/2001 to 7/23/2002. Types of location: Out-patient clinic, Clinical and Translational Research Center (CTRC, formerly General Clinical Research Center), Medical University of South Carolina.

Participant milestones

Participant milestones
Measure	Alendronate Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
Overall Study STARTED	10
Overall Study 6 Months	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Study of Alendronate Sodium in Children With High-Turnover Idiopathic Juvenile Osteoporosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alendronate n=10 Participants Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
Age, Categorical <=18 years	10 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous Pre-Treatment (Baseline)	9.4 years STANDARD_DEVIATION 2.3 • n=5 Participants
Age Continuous Post Treatment	10.6 years STANDARD_DEVIATION 2.3 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: at 12 months

Population: per protocol

Number of participants with increase in bone mineral density at Lumbar Spine and/or Hip at 12 months as compared to the bone mineral density at Lumbar Spine and/or Hip obtained before therapy (baseline values)

Outcome measures

Outcome measures
Measure	Alendronate n=10 Participants Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
Number of Participants With Increased Bone Mineral Density	10 participants 0.11

SECONDARY outcome

Timeframe: Before and 12 months after treatment with alendronate

Population: Per protocol

Participants (pts) with fractures bef.and aft.therapy; pts analysed for average changes in mineral apposition rate (MAR) (high (1.9um/day) to near normal (1.2 um/day)as revealed in bone biopsies. MAR is the distance between the two tetracycline labels (um/day). The data represent the average of 10-17 measurements of the disltance obtained by reading 2-7 individual slides of bone biopsy and pts analysed for average insignificant biochemical markers (serum bone specific alkaline phosphatase for bone formation and urinary N-telopeptide for resorption)to determine the effect of therapy.

Outcome measures

Outcome measures
Measure	Alendronate n=9 Participants Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
Participants (1) With Fractures Before and After Therapy,(2)Analysed for Average Changes From High to Near Normal Mineral Apposition Rate (MAR) After Therapy,(3)Analysed for Average Insignificant Changes in Biochemical Markers After Therapy. Participants with fractures before therapy.	9 participants
Participants (1) With Fractures Before and After Therapy,(2)Analysed for Average Changes From High to Near Normal Mineral Apposition Rate (MAR) After Therapy,(3)Analysed for Average Insignificant Changes in Biochemical Markers After Therapy. Participants with fractures after therapy.	1 participants
Participants (1) With Fractures Before and After Therapy,(2)Analysed for Average Changes From High to Near Normal Mineral Apposition Rate (MAR) After Therapy,(3)Analysed for Average Insignificant Changes in Biochemical Markers After Therapy. Pts average MAR near normal after therapy	9 participants
Participants (1) With Fractures Before and After Therapy,(2)Analysed for Average Changes From High to Near Normal Mineral Apposition Rate (MAR) After Therapy,(3)Analysed for Average Insignificant Changes in Biochemical Markers After Therapy. Pts av biomarker change insignificant aft. therapy	9 participants

Adverse Events

Alendronate

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, M.D., Assistant Professor, Pediatric 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