Trial Outcomes & Findings for Efficacy of Zoledronic Acid in Preventing Collapse of the Osteonecrotic Femoral Head (NCT NCT00939900)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

110 participants

Primary outcome timeframe

Measurements were done at 6, 12, 24 months

Results posted on

2015-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	Aclasta aclasta group zoledronic acid (aclasta): Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period	Control control group
Overall Study STARTED	55	55
Overall Study COMPLETED	53	48
Overall Study NOT COMPLETED	2	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Zoledronic Acid in Preventing Collapse of the Osteonecrotic Femoral Head

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aclasta n=55 Participants aclasta group zoledronic acid (aclasta): Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period	Control n=55 Participants control group	Total n=110 Participants Total of all reporting groups
Age, Continuous	43.8 years STANDARD_DEVIATION 11.8 • n=93 Participants	45.2 years STANDARD_DEVIATION 11.6 • n=4 Participants	44.5 years STANDARD_DEVIATION 11.5 • n=27 Participants
Sex: Female, Male Female	16 Participants n=93 Participants	14 Participants n=4 Participants	30 Participants n=27 Participants
Sex: Female, Male Male	39 Participants n=93 Participants	41 Participants n=4 Participants	80 Participants n=27 Participants

PRIMARY outcome

Timeframe: Measurements were done at 6, 12, 24 months

Outcome measures

Outcome measures
Measure	Aclasta n=53 Participants aclasta group zoledronic acid (aclasta): Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period	Control n=48 Participants control group
Number of Participants With Femoral Head Collapse Within 24 Months	29 participants	22 participants

SECONDARY outcome

Timeframe: Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measurement will be done at 0m, 3m, 6m, 9m, 12m, 18m, 24m)

Outcome measures

Outcome data not reported

Adverse Events

Aclasta

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

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

Professor

SeoulNUBH

Phone: 82317877194

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place