Trial Outcomes & Findings for Alendronate in Juvenile Osteoporosis (NCT NCT00920075)

Results Overview

Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Bone density of spine was measured by DXA scan.

Recruitment status

COMPLETED

Target enrollment

11 participants

Primary outcome timeframe

Post study (1-6 yrs), one clinical visit

Results posted on

2018-07-11

Participant Flow

Participants who have completed our earlier phase-1 and II study on alendronate in juvenile osteoporosis will be invited in this post study to evaluate the bone density/ fractures after discontinuation of therapy. Interested participants will be scheduled for a one time clinic visit. No treatment is involved.

Participants should have completed our earlier phase I or II study on alendronate in juvenile osteoporosis. Participants will be recruited by invitation only.

Participant milestones

Participant milestones
Measure	1 Alendronate for 12 Months, Post Study Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
Post Study, 11 Pts Responded COMPLETED	11
Post Study, 11 Pts Responded NOT COMPLETED	0
Last Study, 25 Pts Invited,11 Responded STARTED	11
Last Study, 25 Pts Invited,11 Responded COMPLETED	11
Last Study, 25 Pts Invited,11 Responded NOT COMPLETED	0
Post Study, 11 Pts Responded STARTED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Alendronate in Juvenile Osteoporosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	1 Alendronate for 12 Months, Post Study n=11 Participants Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
Age, Categorical <=18 years	11 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	12.9 years STANDARD_DEVIATION 2.7 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: Post study (1-6 yrs), one clinical visit

Population: Participants who earlier completed our phase I or phase II study on alendronate in juvenile osteoporosis, were invited to participate in the current post study evaluation of bone density and fractures.

Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Bone density of spine was measured by DXA scan.

Outcome measures

Outcome measures
Measure	1 Alendronate for 12 Months, Post Study n=11 Participants Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
Bone Mineral Density (BMD) of the Lumbar Spine (Participants With Percentage Increase).	11 participants

SECONDARY outcome

Timeframe: Post study (1-6 years), one clincial visit

Population: 11 participants responded to participate in the post study. Their bone density of Hip was measured by DXA scan. Increase in percentage density of Hip was obtained from that of previous values. One participant showed a slight decrease in bone density.

Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Bone density of hip was measured by DXA scan.

Outcome measures

Outcome measures
Measure	1 Alendronate for 12 Months, Post Study n=11 Participants Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
Bone Mineral Density (BMD) of the Hip (Participants With Percentage Increase).	10 participants

SECONDARY outcome

Timeframe: Post study (1-6 years), one clinical visit

Population: 11 participants responded to participate in the post study. During their one clinic visit, their fracture history during the period before coming to the post study was obtained.

Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Their bone densities of spine and hip were measured by DXA scan. During this visit, their fracture history was obtained.

Outcome measures

Outcome measures
Measure	1 Alendronate for 12 Months, Post Study n=11 Participants Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
Number of Participants With Fracture	0 participants

Adverse Events

1 Alendronate for 12 Months, Post Study

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, Asst.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