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

NCT01482858 | Withdrawn

• 1 other identifier: AMCS-003
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

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.

Conditions

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Reduction of pain assessed by change in BPI from baseline to end-of-trial

  baseline to end-of-trial

• Reduction of disability assessed by change in ODI from baseline to end-of-trial

  baseline to end-of-trial

• Reduction of ASOC assessed by weekly change in analgesic consumption diaries from baseline to end of trial

  baseline to end of trial

• All adverse events and serious adverse events will be collected and reported

  Baseline until four (4) weeks after completion of the study.

Study Arms (2)

Gastrolith

EXPERIMENTAL

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

Dietary Supplement: Gastrolith

Placebo

PLACEBO COMPARATOR

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

Interventions

Gastrolith DIETARY_SUPPLEMENT

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

Gastrolith

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amorphical Ltd.: lead

Study Sites (5)

Clalit Health Services - South District

Beersheba, Israel

Location

Soroka Medical Center

Beersheba, Israel

Location

Rambam Medical Center

Haifa, Israel

Location

Hadassah Ein Carem

Jerusalem, Israel

Location

Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Eliad Davidson, MD

  Hadassah Ein Carem Medical Center, Jerusalem, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: In this study the oral calcium treatments are blinded. The subjects, the investigators and any personnel involved in subjects' assessment, monitoring, analysis and data management will be blinded to the subject formulation assignment except the Sponsor who will be responsible for preparing, dispensing and labeling the investigational product IP. Blinded labels will be affixed to the vials prior to dosing by the un-blinded Sponsor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 29, 2011
• First Posted: December 1, 2011
• Study Start: December 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

IL (5)