Clinical trial NCT01482858: Analgesic Effects of the Gastrolith, in Osteoporotic Patients Suffering From Recent Skeletal Pain Caused by Vertebral Fractures
Official title: A Randomized, Double-blind, Placebo-controlled Study Evaluating the Analgesic Effects of the Gastrolith, in Osteoporotic Patients Suffering From Recent Skeletal Pain Caused by Vertebral Fractures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Osteoporosis
Lead sponsor: Amorphical Ltd.
Sponsor class: INDUSTRY
First posted: 2011-12-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective randomized double-blind multicenter study evaluating the safety of GASP and its analgesic effect on pain resulting from OCVF following oral administration of GASP vs. placebo.
Primary purpose: TREATMENT

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, primarily as assessed by the Numeric Rating Scale (NRS), and Brief Pain Inventory (BPI). It is also intended to evaluate disability change with the Oswestry Low Back Pain Disability Index (ODI) and to evaluate whether GASP consumption leads to reduction in analgesic standard of care (ASOC) versus placebo, using weekly analgesic consumption diaries.

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 analgesic effect of GASP on top of the ASOC will be evaluated using weekly NRS and BPI assessments and three ODI questionnaires. Daily ASOC consumption will be monitored using weekly analgesic consumption diaries.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Reduction of pain assessed by change in NRS from baseline to end of the trial
timeFrame: from baseline to end of the trial
Secondary outcomes:
measure: Reduction of pain assessed by change in BPI from baseline to end-of-trial
timeFrame: baseline to end-of-trial
measure: Reduction of disability assessed by change in ODI from baseline to end-of-trial
timeFrame: baseline to end-of-trial
measure: Reduction of ASOC assessed by weekly change in analgesic consumption diaries from baseline to end of trial
timeFrame: baseline to end of trial
measure: All adverse events and serious adverse events will be collected and reported
timeFrame: Baseline until four (4) weeks after completion of the study.
Other outcomes:
Locations:
city: Be'er Sheva
country: Israel
facility: Clalit Health Services - South District
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Ein Carem
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
Study officials:
affiliation: Hadassah Ein Carem Medical Center, Jerusalem, Israel
name: Eliad Davidson, MD
role: PRINCIPAL_INVESTIGATOR
References: