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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Osteoporosis
• Intervention / Treatment: Dietary supplement: Gastrolith; Other: Placebo

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Be'er Sheva, Israel
    • Soroka Medical Center
  • Be'er Sheva, Israel
    • Clalit Health Services - South District
  • Haifa, Israel
    • Rambam Medical Center
  • Jerusalem, Israel
    • Hadassah Ein Carem
  • Tel Aviv, Israel
    • Sourasky Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gastrolith; Gelatin capsules, each containing 500 mg of GASP (comprised of 125 ±5 mg elemental calcium) for oral use.	Dietary supplement: Gastrolith; Gelatin capsules, each containing 500 mg of GASP (comprised of 125 ±5 mg elemental calcium) for oral use.
Placebo Comparator: 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	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of pain assessed by change in NRS 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)	from baseline to end of the trial

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of pain assessed by change in BPI from 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.	baseline to end-of-trial
Reduction of disability assessed by change in ODI from 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.	baseline to end-of-trial
Reduction of ASOC assessed by weekly change in analgesic consumption diaries from 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.	baseline to end of trial
All adverse events and serious adverse events will be collected and reported	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	Baseline until four (4) weeks after completion of the study.

Collaborators and Investigators

• Sponsor: Amorphical Ltd.
• Investigators: Principal Investigator: Eliad Davidson, MD, Hadassah Ein Carem Medical Center, Jerusalem, Israel

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: November 29, 2011
• First Submitted That Met QC Criteria: November 30, 2011
• First Posted (Estimated): December 1, 2011

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 25, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Fractures, Bone; Wounds and Injuries; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Spinal Injuries; Back Injuries; Osteoporosis; Spinal Fractures
• Other Study ID Numbers: AMCS-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No