Back to results

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

Primary Purpose

Osteoporosis

Status

Unknown status

Phase

Phase 4

Locations

Israel

Study Type

Interventional

Intervention

Gastrolith

Placebo

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Clalit Health Services - South District
Soroka Medical Center
Rambam Medical Center
Hadassah Ein Carem
Sourasky Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Gastrolith

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Reduction of pain assessed by change in NRS from baseline to end of the trial

Secondary Outcome Measures

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

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

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

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

Full Information

NCT ID

NCT01482858

First Posted

November 29, 2011

Last Updated

November 30, 2011

Sponsor

Amorphical Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01482858

Brief Title

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

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Unknown status

Study Start Date

December 2011 (undefined)

Primary Completion Date

July 2012 (Anticipated)

Study Completion Date

August 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amorphical Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoporosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Gastrolith

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Gastrolith

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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 Measure Information:

Title

Reduction of pain assessed by change in NRS from baseline to end of the trial

Time Frame

from baseline to end of the trial

Secondary Outcome Measure Information:

Title

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

Time Frame

baseline to end-of-trial

Title

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

Time Frame

baseline to end-of-trial

Title

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

Time Frame

baseline to end of trial

Title

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

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Galit Shaltiel-Glod, PhD

Phone

972 (0)8-6479411-

galits@amorphical.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eliad Davidson, MD

Organizational Affiliation

Hadassah Ein Carem Medical Center, Jerusalem, Israel

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clalit Health Services - South District

City

Be'er Sheva

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pesach Shwartzman, MD

Phone

972-(0)8-6477433

First Name & Middle Initial & Last Name & Degree

Pesach Shwartzman, MD

Facility Name

Soroka Medical Center

City

Be'er Sheva

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pesach Shwartzman, MD

Phone

972-(0)8-6477433

First Name & Middle Initial & Last Name & Degree

Pesach Shwartzman, MD

Facility Name

Rambam Medical Center

City

Haifa

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tsofia Ish-Shalom, MD

Phone

972-(0)4-8541533

First Name & Middle Initial & Last Name & Degree

Tsofia Ish-Shalom, MD

Facility Name

Hadassah Ein Carem

City

Jerusalem

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eliad Davidson, MD

Phone

972-(0)2-6776911

First Name & Middle Initial & Last Name & Degree

Eliad Davidson, MD

Facility Name

Sourasky Medical Center

City

Tel Aviv

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sylvio Brill, MD

Phone

972-(0)3-6974581

First Name & Middle Initial & Last Name & Degree

Sylvio Brill, MD

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs