Trial Outcomes & Findings for Pilot Study of Fosamax in Spinal Cord Injury (NCT NCT01131884)

Last Updated: 2016-01-29

Results Overview

Whether or not Fosamax increases bone mineral density at the hip and distal femur in spinal cord injury induced osteoporosis

Recruitment status

TERMINATED

Study phase

Target enrollment

1 participants

Primary outcome timeframe

1 year after enrollment

Results posted on

2016-01-29

Participant Flow

A 57 year old T4 paraplegic was recruited while he was going through rehabilitation at Strong Memorial Hospital inpatient rehab unit. This patient was recruited and signed consent on 8/05/2011.He underwent lab work and dexa scan per protocol and on completion of the investigation on September 19, 2011 he started the treatment(Fosamax vs. Placebo).

Recruitment beyond one patient was not possible due to A. surgeons unwillingness to initiate Fosomax treatment for fear of wound healing. B. The eligible patients' reluctance to participate in the study. C. Given the length of time it took to enroll one, it is not feasible to complete the study with required # in the protocol in the next few years

Participant milestones

Participant milestones
Measure	Fosamax Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year	Placebo Sugar Pill Double blind study using Fosamax versus placebo. Placebo is an inactive drug. Placebo : Placebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo.
Overall Study STARTED	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study of Fosamax in Spinal Cord Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fosamax n=1 Participants Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year	Placebo Sugar Pill Double blind study using Fosamax versus placebo. Placebo is an inactive drug. Placebo : Placebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo.	Total n=1 Participants Total of all reporting groups
Age, Categorical <=18 years	0 participants n=5 Participants	—	0 participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 participants n=5 Participants	—	1 participants n=5 Participants
Age, Categorical >=65 years	0 participants n=5 Participants	—	0 participants n=5 Participants
Age, Continuous	58 years STANDARD_DEVIATION 0 • n=5 Participants	—	58 years STANDARD_DEVIATION 0 • n=5 Participants
Gender Female	0 participants n=5 Participants	—	0 participants n=5 Participants
Gender Male	1 participants n=5 Participants	—	1 participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	—	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year after enrollment

Population: No analysis performed as there was only one patient who participated in this study

Whether or not Fosamax increases bone mineral density at the hip and distal femur in spinal cord injury induced osteoporosis

Outcome measures

Outcome data not reported

Adverse Events

Fosamax

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Sugar Pill

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

K.Rao Poduri, M.D., Chair of Physical Medicine & Rehab

University of Rochester

Phone: 585-275-6978

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place