Phase 3
N=712
Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis
Osteoporosis, Postmenopausal · Back Pain · Spinal Fracture
Bottom Line
View on ClinicalTrials.gov: NCT00343252 ↗Enrolled (actual)
712
Serious AEs
17.0%
Results posted
Jul 2010
Primary outcome: Primary: Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint — 206; 193; 142; 143 participants — p=0.642
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- teriparatide (Drug); risedronate (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Female
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 6-Month Endpoint |
206; 193; 142; 143 | 0.642 |
| SECONDARY Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 12-Month Endpoint |
233; 220; 115; 116 | 0.683 |
| SECONDARY Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 6-Month Endpoint |
221; 211; 126; 125 | 0.809 |
| SECONDARY Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 12-Month Endpoint |
246; 238; 101; 98 | 0.986 |
| SECONDARY Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 6 Months |
0; 0; 26; 22; 70; 74 | 0.746 |
| SECONDARY Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 12 Months |
0; 0; 70; 74; 151; 145 | 0.719 |
| SECONDARY Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 6 Months |
0; 0; 40; 33; 91; 86 | 0.681 |
| SECONDARY Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 12 Months |
0; 0; 91; 86; 175; 162 | 0.789 |
| SECONDARY Change From Baseline to 3-Month Endpoint in the Roland-Morris Disability Questionnaire. |
-1.42; -1.41 | 0.968 |
| SECONDARY Change From Baseline to 6-Month Endpoint in the Roland-Morris Disability Questionnaire. |
-1.58; -1.77 | 0.568 |
| SECONDARY Change From Baseline to 12-Month Endpoint in the Roland-Morris Disability Questionnaire. |
-2.09; -2.12 | 0.932 |
| SECONDARY Change From Baseline to 6-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO) |
-2.80; -2.63 | 0.814 |
| SECONDARY Change From Baseline to 12-Month Endpoint, European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO) |
-5.74; -5.27 | 0.572 |
| SECONDARY Number of Participants With Adverse Events (Safety) During 12 Months |
39; 50; 269; 266 | — |
| SECONDARY Number of Participants With Adverse Events (Safety) During 18 Months |
55; 66; 277; 273 | — |
| SECONDARY Number of Participants Responding With at Least a 30% Reduction in 24-Hour Worst Back Pain Severity at the 18-Month Endpoint |
248; 234; 112; 115 | 0.600 |
| SECONDARY Number of Participants Responding With at Least a 30% Reduction in 24-Hour Average Back Pain Severity at the 18-Month Endpoint |
260; 242; 100; 107 | 0.399 |
| SECONDARY Number of Participants With Time to First Occurrence of at Least 30% Reduction in 24-Hour Worst Back Pain up to 18 Months |
248; 234 | 0.453 |
| SECONDARY Number of Participants With Time to First Occurrence of at Least a 30% Reduction in 24-Hour Average Back Pain up to 18 Months |
260; 242 | 0.353 |
| SECONDARY Change From Baseline to 18-Month Endpoint in the Roland-Morris Disability Questionnaire. |
-3.21; -3.19 | 0.943 |
| SECONDARY Change From Baseline to 18-Month Endpoint in European Foundation for Osteoporosis Quality of Life Instrument (QUALEFFO) |
-5.67; -5.17 | 0.553 |
Summary
The purpose of the study is to determine if daily teriparatide reduces back pain more effectively than weekly risedronate in women with osteoporosis who have chronic back pain due to a spinal bone fracture.
Eligibility Criteria
Inclusion Criteria
- Postmenopausal women 45 years or older. No period for at least two years.
- History of back pain that started at least 2 months prior to the initial visit (likely due to spinal bone fracture determined by investigator).
- Minimum of one moderate spinal bone fracture.
- Beginning pain level of at least four on an eleven point scale.
- Bone Mineral Density (BMD) must meet criteria
- Able to read, understand, and administer self-questionnaires.
- Be willing and able to use a pen-injector to deliver the medication.
Exclusion Criteria
- Are at increased risk for osteosarcoma.
- Have an active or suspected diseases that affects bone metabolism other than osteoporosis.
- Participants that already know that they will require procedures to repair their spinal bone fractures.
- Abnormal values of certain lab tests.
- Anything that would make it difficult to determine if the back pain was due to the fracture.
- Poor medical or psychiatric condition.
- Alcohol or drug abuse within a year of the study start.
- Certain malignant neoplasms in the 5 years prior to enrollment.
- Active liver disease or clinical jaundice.
- Significantly impaired renal function.
- History of nephrolithiasis or urolithiasis within 2 years prior to enrollment.
- Known contraindication or intolerance to risedronate and/or teriparatide therapy.
- Treatment with oral strontium or certain therapeutic doses of fluoride.
Data sourced from ClinicalTrials.gov (NCT00343252). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.