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Trial record 18 of 101 for:    Risedronate

Combination Risedronate - Parathyroid Hormone Trial in Male Osteoporosis (RPM)

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ClinicalTrials.gov Identifier: NCT01611571
Recruitment Status : Completed
First Posted : June 5, 2012
Results First Posted : March 4, 2014
Last Update Posted : March 4, 2014
Sponsor:
Collaborator:
Alliance for Better Bone Health
Information provided by (Responsible Party):
Marcella Walker, Columbia University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Osteoporosis
Interventions Drug: Risedronate
Drug: Teriparatide
Drug: Placebo Teriparatide
Drug: placebo Risedronate
Enrollment 31
Recruitment Details beginning 12/23/2003 and ending 11/2008 a total of 31 participants were enrolled in this study.
Pre-assignment Details  
Arm/Group Title Active Risedronate + Active Teriparatide Active Risedronte + Placebo Teriparatide Placebo Risedronate + Active Teriparatide, Active Risedronate
Hide Arm/Group Description

Active Risedronate Active Teriparatide

Risedronic acid & teriparatide : weekly risedronate daily teriparatide

Active Risedronte Placebo Teriparatide

Risedronic acid : weekly risedronate daily teriparatide (placebo)

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

Period Title: Overall Study
Started 11 10 10
Completed 10 10 9
Not Completed 1 0 1
Arm/Group Title Active Risedronate Active Teriparatide Active Risedronte Placebo Teriparatide Placebo Risedronate Active Teriparatide, Active Risedronate Total
Hide Arm/Group Description

Active Risedronate Active Teriparatide

Risedronic acid & teriparatide : weekly risedronate daily teriparatide

Active Risedronte Placebo Teriparatide

Risedronic acid : weekly risedronate daily teriparatide (placebo)

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 of all reporting groups
Overall Number of Baseline Participants 11 10 10 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 10 participants 31 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
 100.0%
10
 100.0%
10
 100.0%
31
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 10 participants 10 participants 31 participants
56.7  (4.9) 54  (2) 51.6  (3.9) 51.6  (3.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 10 participants 31 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
11
 100.0%
10
 100.0%
10
 100.0%
31
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 10 participants 10 participants 31 participants
11 10 10 31
1.Primary Outcome
Title Change in Spine Bone Density
Hide Description change in spine bone density at 18 months measured by DXA 18 and 24 months
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Risedronate Active Teriparatide Active Risedronte Placebo Teriparatide Placebo Risedronate Active Teriparatide
Hide Arm/Group Description:

Active Risedronate Active Teriparatide

Risedronic acid & teriparatide : weekly risedronate daily teriparatide

Active Risedronte Placebo Teriparatide

Risedronic acid : weekly risedronate daily teriparatide (placebo)

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 Number of Participants Analyzed 10 10 9
Least Squares Mean (Standard Deviation)
Unit of Measure: % change in LS BMD
6.95  (1.9) 3.76  (1.8) 5.68  (1.9)
2.Secondary Outcome
Title Change in Hip Bone Density
Hide Description change in hip bone density measured by DXA
Time Frame baseline and 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Risedronate Active Teriparatide Active Risedronte Placebo Teriparatide Placebo Risedronate Active Teriparatide
Hide Arm/Group Description:

Active Risedronate Active Teriparatide

Risedronic acid & teriparatide : weekly risedronate daily teriparatide

Active Risedronte Placebo Teriparatide

Risedronic acid : weekly risedronate daily teriparatide (placebo)

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 Number of Participants Analyzed 10 10 9
Mean (Standard Deviation)
Unit of Measure: % change in TH BMD
3.86  (1.1) 0.82  (0.95) 0.29  (0.95)
3.Secondary Outcome
Title Change in Forearm Bone Density
Hide Description change in 1/3 radius of forearm bone density as measured by DXA
Time Frame baseline and 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Risedronate Active Teriparatide Active Risedronte Placebo Teriparatide Placebo Risedronate Active Teriparatide
Hide Arm/Group Description:

Active Risedronate Active Teriparatide

Risedronic acid & teriparatide : weekly risedronate daily teriparatide

Active Risedronte Placebo Teriparatide

Risedronic acid : weekly risedronate daily teriparatide (placebo)

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 Number of Participants Analyzed 10 10 9
Mean (Standard Deviation)
Unit of Measure: % change in 1/3 Radius BMD
1.6  (0.6) 0.11  (0.77) 0.02  (0.77)
4.Secondary Outcome
Title New Morphometric Vertebral Fractures
Hide Description counting the total new morphometric vertebral fractures as determined by x-ray from baseline through end of study
Time Frame baseline through 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Risedronate Active Teriparatide Active Risedronte Placebo Teriparatide Placebo Risedronate Active Teriparatide
Hide Arm/Group Description:

Active Risedronate Active Teriparatide

Risedronic acid & teriparatide : weekly risedronate daily teriparatide

Active Risedronte Placebo Teriparatide

Risedronic acid : weekly risedronate daily teriparatide (placebo)

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 Number of Participants Analyzed 10 10 9
Measure Type: Number
Unit of Measure: vertebral fracture
1 1 0
5.Secondary Outcome
Title Change in FN BMD at 18 Months
Hide Description Change in the Femoral Neck BMD at 18 month
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Risedronate Active Teriparatide Active Risedronte Placebo Teriparatide Placebo Risedronate Active Teriparatide
Hide Arm/Group Description:

Active Risedronate Active Teriparatide

Risedronic acid & teriparatide : weekly risedronate daily teriparatide

Active Risedronte Placebo Teriparatide

Risedronic acid : weekly risedronate daily teriparatide (placebo)

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 Number of Participants Analyzed 10 10 9
Mean (Standard Deviation)
Unit of Measure: % change in TH BMD
8.45  (1.8) 0.5  (1.7) 3.89  (1.7)
Time Frame each participant was enrolled for a total of 24 months and adverse events were collected throughout the entirety of their participation.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Risedronate Active Teriparatide Active Risedronte Placebo Teriparatide Placebo Risedronate Active Teriparatide, Active Risedronate
Hide Arm/Group Description

Active Risedronate Active Teriparatide

Risedronic acid & teriparatide : weekly risedronate daily teriparatide

Active Risedronte Placebo Teriparatide

Risedronic acid : weekly risedronate daily teriparatide (placebo)

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

All-Cause Mortality
Active Risedronate Active Teriparatide Active Risedronte Placebo Teriparatide Placebo Risedronate Active Teriparatide, Active Risedronate
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Active Risedronate Active Teriparatide Active Risedronte Placebo Teriparatide Placebo Risedronate Active Teriparatide, Active Risedronate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)      0/9 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Active Risedronate Active Teriparatide Active Risedronte Placebo Teriparatide Placebo Risedronate Active Teriparatide, Active Risedronate
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/10 (60.00%)      3/10 (30.00%)      2/9 (22.22%)    
Endocrine disorders       
Fracture, vertebral  [1]  1/10 (10.00%)  1 1/10 (10.00%)  1 0/9 (0.00%)  0
Fatigue *  0/10 (0.00%)  0 1/10 (10.00%)  1 0/9 (0.00%)  0
Gastrointestinal disorders       
Gastroesophageal Reflux *  1/10 (10.00%)  4 1/10 (10.00%)  3 0/9 (0.00%)  0
Difficulty Swallowing *  0/10 (0.00%)  0 1/10 (10.00%)  1 0/9 (0.00%)  0
Injury, poisoning and procedural complications       
Fracture, patella  [2]  1/10 (10.00%)  1 0/10 (0.00%)  0 0/9 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Leg Cramping * [3]  1/10 (10.00%)  1 1/10 (10.00%)  1 1/9 (11.11%)  1
Renal and urinary disorders       
Nephrolithiasis   2/10 (20.00%)  2 0/10 (0.00%)  0 0/9 (0.00%)  0
Skin and subcutaneous tissue disorders       
Injection Site Irritation   2/10 (20.00%)  4 3/10 (30.00%)  6 1/9 (11.11%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
new vertebral fracture
[2]
fracture of the left patella. This fracture not deemed to be a fragility fracture or in any way related to study drug or participation in the study.
[3]
participants experienced either leg cramping for the first time, or worsening of existing leg cramping
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Marcella Walker MD
Organization: Columbia University Medical Center
Phone: 212-342-5351
Responsible Party: Marcella Walker, Columbia University
ClinicalTrials.gov Identifier: NCT01611571     History of Changes
Other Study ID Numbers: AAAA4304
First Submitted: May 29, 2012
First Posted: June 5, 2012
Results First Submitted: August 20, 2013
Results First Posted: March 4, 2014
Last Update Posted: March 4, 2014