Analgesic Effects of the Gastrolith, in Osteoporotic Patients Suffering From Recent Skeletal Pain Caused by Vertebral Fractures

Not Applicable

Withdrawn

• Conditions: Osteoporosis
• Interventions: Dietary Supplement: Gastrolith; Other: Placebo

• Registration Number: NCT01482858
• Lead Sponsor: Amorphical Ltd.

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.

Study Timeline

• Study First Submitted: 2011-11-29
• Study First Submitted QC: 2011-11-30
• Study Start: 2011-12
• Study First Posted: 2011-12-01
• Primary Completion: 2012-07
• Study Completion: 2012-08
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-25
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gastrolith	Gastrolith	Gelatin capsules, each containing 500 mg of GASP (comprised of 125 ±5 mg elemental calcium) for oral use.
Placebo	Placebo	Gelatin capsules, each containing 500 mg \[comprised of 312.5 mg calcium carbonate (125 ±5 mg elemental calcium) and 187.5 mg of sucrose\] for oral use as placebo

Primary Outcome Measures

Name	Time	Method
Reduction of pain assessed by change in NRS from baseline to end of the trial	from baseline to end of the trial	• Change from baseline to end-of-trial on NRS during movement (scale of 0 to 10) computed as follows.; NRSchange = NRS42 - NRS0 NRS42 - NRS score at day 42 (end-of-trial) NRS0 - NRS score at day 0 (baseline)

Secondary Outcome Measures

Name	Time	Method
Reduction of pain assessed by change in BPI from baseline to end-of-trial	baseline to end-of-trial	The BPI uses 0 to 10 numeric rating scales for item rating because of its simplicity, lack of ambiguity and seemed the best to use for cross-linguistic pain measurement. Since pain can be quite variable over a day, the BPI asks subjects to rate their pain at the time of responding to the questionnaire (pain now), and also at its worst, least, and average over the previous week. The ratings can also be made for the last 24 hours.
Reduction of disability assessed by change in ODI from baseline to end-of-trial	baseline to end-of-trial	Oswestry Low Back Pain Disability Questionnaire - comprises of 10 sections describing the pain and its impact, each scored from 0 to 5 with higher values indicating more severe impact.
Reduction of ASOC assessed by weekly change in analgesic consumption diaries from baseline to end of trial	baseline to end of trial	Analgesic drug consumption will be daily self-recorded by subjects in a diary bearing drug's name and daily dose. The number of tablets taken each day will be noted in each category.
All adverse events and serious adverse events will be collected and reported	Baseline until four (4) weeks after completion of the study.	An adverse event is any untoward medical sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of the IPs whether or not considered as IP related. A new condition or the worsening of a pre-existing condition will be considered an AE. All abnormal findings considered to be clinically significant must be recorded as adverse events

Trial Locations

Locations (5)

Clalit Health Services - South District; 🇮🇱 Be'er Sheva, Israel

Soroka Medical Center; 🇮🇱 Be'er Sheva, Israel

Rambam Medical Center; 🇮🇱 Haifa, Israel

Hadassah Ein Carem; 🇮🇱 Jerusalem, Israel

Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel