Trial Outcomes & Findings for Secondary Prevention of Osteoporosis (NCT NCT00421343)

NCT ID: NCT00421343

Last Updated: 2020-02-05

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 29 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2020-02-05

Participant Flow

Participant milestones

Measure	Osteoporosis Medication Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week.
Overall Study STARTED	29
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Osteoporosis Medication Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week.
Overall Study Death	1
Overall Study Withdrawal by Subject	2
Overall Study Lost to Follow-up	3

Baseline Characteristics

Secondary Prevention of Osteoporosis

Baseline characteristics by cohort

Measure	Osteoporosis Medication n=29 Participants Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	28 Participants n=5 Participants
Age, Continuous	80 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	Osteoporosis Medication n=29 Participants Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week.
Number Adherent With the Intervention	29 participants

SECONDARY outcome

Timeframe: 6 months

We asked participants who would not participate the primary reason for non-particiaption. We also asked participants who were not adherent with recommendations what the primary reason ws for non-adherence.

Outcome measures

Outcome data not reported

Adverse Events

Osteoporosis Medication

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Osteoporosis Medication n=29 participants at risk Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week.
Injury, poisoning and procedural complications death	3.4% 1/29 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Sarah Berry

Hebrew SeiorLife

Phone: 617-971-5355

Email: sarahberry@hrca.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place