Status:
WITHDRAWN
Analgesic Effects of the Gastrolith, in Osteoporotic Patients Suffering From Recent Skeletal Pain Caused by Vertebral Fractures
Lead Sponsor:
Amorphical Ltd.
Conditions:
Osteoporosis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This study aims to evaluate the safety and analgesic effect (efficacy) of Gastrolith powder (GASP) on skeletal pain caused by osteoporotic vertebral compression fractures (OVCF) versus placebo, primar...
Detailed Description
Eighty (80) Osteoporotic subjects with recent reported severe back pain caused by OVCF will be blindly randomized into two groups (n=40 each). One group will receive GASP and the other Placebo. The a...
Eligibility Criteria
Inclusion
- Osteoporotic patients aged 18-80 years old, inclusive.
- Diagnosed Osteoporotic vertebral compression fracture(s) in at least one vertebra caused by an atraumatic event or a minimal traumatic event such as falling from standing height or less, or by other minimal trauma besides a fall (see section 4.2 Table I for definitions), and visible by either X-ray radiography, CT or MRI.
- At least six (6) weeks and no more than six (6) months from the onset of severe back pain suspected to be caused by the OVCF.
- Presenting a score of ≥5 in the pain NRS during movement (getting up from a chair).
- Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- Subject that had signed the ICF.
Exclusion
- More than six (6) months from the onset of severe back pain suspected to be caused by OVCF.Subjects after vertebroplasty or kyphoplasty.
- Hypercalcemic subjects (calcium \> 10.50 mg/dL).
- Subjects with renal diseases.
- Subjects with active malignancy or other active metabolic bone disease which is not osteoporosis.
- Subjects with cognitive impairments.
- Pregnant or breastfeeding women.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01482858
Start Date
December 1 2011
End Date
August 1 2012
Last Update
February 28 2024
Active Locations (5)
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1
Clalit Health Services - South District
Beersheba, Israel
2
Soroka Medical Center
Beersheba, Israel
3
Rambam Medical Center
Haifa, Israel
4
Hadassah Ein Carem
Jerusalem, Israel