Trial Outcomes & Findings for Risedronate and Parathyroid Hormone to Reverse Osteoporosis Caused by Chronic Steroid Use (NCT NCT00221299)
NCT ID: NCT00221299
Last Updated: 2015-06-25
Results Overview
In this randomized clinical trial to determine if treatment with rhPTH (1-34) with and without risedronate will increase bone mass of the lumbar spine more than risedronate alone. This was a small pilot study and study subjects were recruited from two study sites. Our primary endpoint was change in lumbar spine BMD.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
BMD changes from year 1 to year 2
Results posted on
2015-06-25
Participant Flow
Participant milestones
| Measure |
Group1a-rhPTH&RIS-Placebo(Y1)&RIS(Y2)
First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate placebo tablets for one year Second phase (year 2) - re-randomized to risedronate (35mg/wk) tablets for second year.
Risedronate: One 35mg tab of risedronate/placebo taken once a week for year 1. One 35mg tab of risedronate taken once a week for year 2.
Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year.
|
Group1b-rhPTH&RisendronatePlacebo
First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate placebo tablets for one year Second phase (year 2) - continue on risedronate placebo tablets for second year.
Risedronate: One 35mg tab of risedronate/placebo taken once a week for two years.
Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year.
|
Group2-rhPTH&Risedronate
First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate tablets (35mg/wk) tablets for one year Second phase (year 2) - continue on risedronate tablets (35mg/wk) for second year.
Risedronate: One 35mg tab of risedronate/placebo taken once a week for two years.
Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year.
|
Group3-rhPTH-Placebo&Risedronate
First phase (year 1) - parathyroid hormone (rhPTH 1-34), placebo SC injections of normal saline daily and risedronate tablets (35mg/wk) tablets for one year Second phase (year 2) - continue on risedronate tablets (35mg/wk) for second year.
Risedronate: One 35mg tab of risedronate/placebo taken once a week for two years.
Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
13
|
14
|
11
|
|
Overall Study
COMPLETED
|
10
|
11
|
14
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Risedronate and Parathyroid Hormone to Reverse Osteoporosis Caused by Chronic Steroid Use
Baseline characteristics by cohort
| Measure |
Parathyroid Hormone Injections and Risedronate Placebo Tablets
n=24 Participants
parathyroid hormone (rhPTH 1-34) injections and risedronate placebo tablets for one year
Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year.
|
Parathyroid Hormone Injections and Risedronate Tablets
n=14 Participants
Parathyroid hormone (rhPTH 1-34) injections and risedronate tablets for one year
Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year.
Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year.
|
Parathyroid Hormone Placebo Injections and Risedronate Tables
n=11 Participants
parathyroid hormone (rhPTH 1-34) placebo injections and risedronate tablets for one year
Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50.4 years
STANDARD_DEVIATION 14 • n=5 Participants
|
48.3 years
STANDARD_DEVIATION 14.9 • n=7 Participants
|
53 years
STANDARD_DEVIATION 18.8 • n=5 Participants
|
50.6 years
STANDARD_DEVIATION 15.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
14 participants
n=7 Participants
|
11 participants
n=5 Participants
|
49 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: BMD changes from year 1 to year 2Population: Per protocol
In this randomized clinical trial to determine if treatment with rhPTH (1-34) with and without risedronate will increase bone mass of the lumbar spine more than risedronate alone. This was a small pilot study and study subjects were recruited from two study sites. Our primary endpoint was change in lumbar spine BMD.
Outcome measures
| Measure |
Parathyroid Hormone&Risedronate Placebo
n=21 Participants
parathyroid hormone (rhPTH 1-34) injections and risedronate placebo tablets for one year
Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year.
|
Parathyroid Hormone&Risedronate
n=14 Participants
Parathyroid hormone (rhPTH 1-34) injections and risedronate tablets for one year
Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year.
Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year.
|
Parathyroid Hormone Placebo&Risedronate
n=10 Participants
parathyroid hormone (rhPTH 1-34) placebo injections and risedronate tablets for one year
Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year.
|
|---|---|---|---|
|
Bone Mineral Density (BMD): Examine the Pattern and Effect of BMD Changes at Hip and Spine Measured by DXA Every 6 Months.
|
0.85 percent change
Standard Deviation 0.10
|
0.84 percent change
Standard Deviation 0.12
|
0.91 percent change
Standard Deviation 0.11
|
Adverse Events
Parathyroid Hormone Injections and Risedronate Placebo Tablets
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Parthyroid Hormone Injections and Risedronte Tablets
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Parathyroid Hormone Placebo Injections and Risedronate Tablets
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
Nancy E. Lane MD, Director, Center for Musculoskeletal Health
Unversity of California Davis
Phone: 916 734-0753
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place