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

Osteoporosis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01482858
• Other study ID #: AMCS-003
• Status: Withdrawn
• Phase: N/A
• Start date: December 2011
• Est. completion date: August 2012

Study information

• Verified date: February 2024
• Source: Amorphical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis
• Spinal Fractures

Intervention

Dietary Supplement:
• Gastrolith
Gelatin capsules, each containing 500 mg of GASP (comprised of 125 ±5 mg elemental calcium) for oral use.

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

Locations

Country	Name	City	State
Israel	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

Sponsors (1)

Lead Sponsor	Collaborator
Amorphical Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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.