Trial Outcomes & Findings for Combination Risedronate - Parathyroid Hormone Trial in Male Osteoporosis (NCT NCT01611571)

NCT ID: NCT01611571

Last Updated: 2014-03-04

Results Overview

change in spine bone density at 18 months measured by DXA 18 and 24 months

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 31 participants
• Primary outcome timeframe: 18 months
• Results posted on: 2014-03-04

Participant Flow

beginning 12/23/2003 and ending 11/2008 a total of 31 participants were enrolled in this study.

Participant milestones

Measure	Active Risedronate + Active Teriparatide Active Risedronate Active Teriparatide Risedronic acid \& teriparatide : weekly risedronate daily teriparatide	Active Risedronte + Placebo Teriparatide Active Risedronte Placebo Teriparatide Risedronic acid : weekly risedronate daily teriparatide (placebo)	Placebo Risedronate + Active Teriparatide, Active Risedronate Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months
Overall Study STARTED	11	10	10
Overall Study COMPLETED	10	10	9
Overall Study NOT COMPLETED	1	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Combination Risedronate - Parathyroid Hormone Trial in Male Osteoporosis

Baseline characteristics by cohort

Measure	Active Risedronate Active Teriparatide n=11 Participants Active Risedronate Active Teriparatide Risedronic acid \& teriparatide : weekly risedronate daily teriparatide	Active Risedronte Placebo Teriparatide n=10 Participants Active Risedronte Placebo Teriparatide Risedronic acid : weekly risedronate daily teriparatide (placebo)	Placebo Risedronate Active Teriparatide, Active Risedronate n=10 Participants Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	31 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	56.7 years STANDARD_DEVIATION 4.9 • n=5 Participants	54 years STANDARD_DEVIATION 2 • n=7 Participants	51.6 years STANDARD_DEVIATION 3.9 • n=5 Participants	51.6 years STANDARD_DEVIATION 3.9 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	31 Participants n=4 Participants
Region of Enrollment United States	11 participants n=5 Participants	10 participants n=7 Participants	10 participants n=5 Participants	31 participants n=4 Participants

PRIMARY outcome

Timeframe: 18 months

change in spine bone density at 18 months measured by DXA 18 and 24 months

Outcome measures

Measure	Active Risedronate Active Teriparatide n=10 Participants Active Risedronate Active Teriparatide Risedronic acid \& teriparatide : weekly risedronate daily teriparatide	Active Risedronte Placebo Teriparatide n=10 Participants Active Risedronte Placebo Teriparatide Risedronic acid : weekly risedronate daily teriparatide (placebo)	Placebo Risedronate Active Teriparatide n=9 Participants Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months
Change in Spine Bone Density	6.95 % change in LS BMD Standard Deviation 1.9	3.76 % change in LS BMD Standard Deviation 1.8	5.68 % change in LS BMD Standard Deviation 1.9

SECONDARY outcome

Timeframe: baseline and 18 months

change in hip bone density measured by DXA

Outcome measures

Measure	Active Risedronate Active Teriparatide n=10 Participants Active Risedronate Active Teriparatide Risedronic acid \& teriparatide : weekly risedronate daily teriparatide	Active Risedronte Placebo Teriparatide n=10 Participants Active Risedronte Placebo Teriparatide Risedronic acid : weekly risedronate daily teriparatide (placebo)	Placebo Risedronate Active Teriparatide n=9 Participants Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months
Change in Hip Bone Density	3.86 % change in TH BMD Standard Deviation 1.1	0.82 % change in TH BMD Standard Deviation 0.95	0.29 % change in TH BMD Standard Deviation 0.95

SECONDARY outcome

Timeframe: baseline and 18 months

change in 1/3 radius of forearm bone density as measured by DXA

Outcome measures

Measure	Active Risedronate Active Teriparatide n=10 Participants Active Risedronate Active Teriparatide Risedronic acid \& teriparatide : weekly risedronate daily teriparatide	Active Risedronte Placebo Teriparatide n=10 Participants Active Risedronte Placebo Teriparatide Risedronic acid : weekly risedronate daily teriparatide (placebo)	Placebo Risedronate Active Teriparatide n=9 Participants Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months
Change in Forearm Bone Density	1.6 % change in 1/3 Radius BMD Standard Deviation 0.6	0.11 % change in 1/3 Radius BMD Standard Deviation 0.77	0.02 % change in 1/3 Radius BMD Standard Deviation 0.77

SECONDARY outcome

Timeframe: baseline through 18 months

counting the total new morphometric vertebral fractures as determined by x-ray from baseline through end of study

Outcome measures

Measure	Active Risedronate Active Teriparatide n=10 Participants Active Risedronate Active Teriparatide Risedronic acid \& teriparatide : weekly risedronate daily teriparatide	Active Risedronte Placebo Teriparatide n=10 Participants Active Risedronte Placebo Teriparatide Risedronic acid : weekly risedronate daily teriparatide (placebo)	Placebo Risedronate Active Teriparatide n=9 Participants Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months
New Morphometric Vertebral Fractures	1 vertebral fracture	1 vertebral fracture	0 vertebral fracture

SECONDARY outcome

Timeframe: 18 months

Change in the Femoral Neck BMD at 18 month

Outcome measures

Measure	Active Risedronate Active Teriparatide n=10 Participants Active Risedronate Active Teriparatide Risedronic acid \& teriparatide : weekly risedronate daily teriparatide	Active Risedronte Placebo Teriparatide n=10 Participants Active Risedronte Placebo Teriparatide Risedronic acid : weekly risedronate daily teriparatide (placebo)	Placebo Risedronate Active Teriparatide n=9 Participants Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months
Change in FN BMD at 18 Months	8.45 % change in TH BMD Standard Deviation 1.8	0.5 % change in TH BMD Standard Deviation 1.7	3.89 % change in TH BMD Standard Deviation 1.7

Adverse Events

Active Risedronate Active Teriparatide

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Active Risedronte Placebo Teriparatide

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo Risedronate Active Teriparatide, Active Risedronate

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Active Risedronate Active Teriparatide n=10 participants at risk Active Risedronate Active Teriparatide Risedronic acid \& teriparatide : weekly risedronate daily teriparatide	Active Risedronte Placebo Teriparatide n=10 participants at risk Active Risedronte Placebo Teriparatide Risedronic acid : weekly risedronate daily teriparatide (placebo)	Placebo Risedronate Active Teriparatide, Active Risedronate n=9 participants at risk Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months
Injury, poisoning and procedural complications Fracture, patella	10.0% 1/10 • Number of events 1 • each participant was enrolled for a total of 24 months and adverse events were collected throughout the entirety of their participation.	0.00% 0/10 • each participant was enrolled for a total of 24 months and adverse events were collected throughout the entirety of their participation.	0.00% 0/9 • each participant was enrolled for a total of 24 months and adverse events were collected throughout the entirety of their participation.
Endocrine disorders Fracture, vertebral	10.0% 1/10 • Number of events 1 • each participant was enrolled for a total of 24 months and adverse events were collected throughout the entirety of their participation.	10.0% 1/10 • Number of events 1 • each participant was enrolled for a total of 24 months and adverse events were collected throughout the entirety of their participation.	0.00% 0/9 • each participant was enrolled for a total of 24 months and adverse events were collected throughout the entirety of their participation.
Endocrine disorders Fatigue	0.00% 0/10 • each participant was enrolled for a total of 24 months and adverse events were collected throughout the entirety of their participation.	10.0% 1/10 • Number of events 1 • each participant was enrolled for a total of 24 months and adverse events were collected throughout the entirety of their participation.	0.00% 0/9 • each participant was enrolled for a total of 24 months and adverse events were collected throughout the entirety of their participation.
Gastrointestinal disorders Gastroesophageal Reflux	10.0% 1/10 • Number of events 4 • each participant was enrolled for a total of 24 months and adverse events were collected throughout the entirety of their participation.	10.0% 1/10 • Number of events 3 • each participant was enrolled for a total of 24 months and adverse events were collected throughout the entirety of their participation.	0.00% 0/9 • each participant was enrolled for a total of 24 months and adverse events were collected throughout the entirety of their participation.
Skin and subcutaneous tissue disorders Injection Site Irritation	20.0% 2/10 • Number of events 4 • each participant was enrolled for a total of 24 months and adverse events were collected throughout the entirety of their participation.	30.0% 3/10 • Number of events 6 • each participant was enrolled for a total of 24 months and adverse events were collected throughout the entirety of their participation.	11.1% 1/9 • Number of events 1 • each participant was enrolled for a total of 24 months and adverse events were collected throughout the entirety of their participation.
Gastrointestinal disorders Difficulty Swallowing	0.00% 0/10 • each participant was enrolled for a total of 24 months and adverse events were collected throughout the entirety of their participation.	10.0% 1/10 • Number of events 1 • each participant was enrolled for a total of 24 months and adverse events were collected throughout the entirety of their participation.	0.00% 0/9 • each participant was enrolled for a total of 24 months and adverse events were collected throughout the entirety of their participation.
Musculoskeletal and connective tissue disorders Leg Cramping	10.0% 1/10 • Number of events 1 • each participant was enrolled for a total of 24 months and adverse events were collected throughout the entirety of their participation.	10.0% 1/10 • Number of events 1 • each participant was enrolled for a total of 24 months and adverse events were collected throughout the entirety of their participation.	11.1% 1/9 • Number of events 1 • each participant was enrolled for a total of 24 months and adverse events were collected throughout the entirety of their participation.
Renal and urinary disorders Nephrolithiasis	20.0% 2/10 • Number of events 2 • each participant was enrolled for a total of 24 months and adverse events were collected throughout the entirety of their participation.	0.00% 0/10 • each participant was enrolled for a total of 24 months and adverse events were collected throughout the entirety of their participation.	0.00% 0/9 • each participant was enrolled for a total of 24 months and adverse events were collected throughout the entirety of their participation.

Additional Information

Marcella Walker MD

Columbia University Medical Center

Phone: 212-342-5351

Email: mad2037@columbia.edu

Results disclosure agreements

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