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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2011 by Amorphical Ltd..
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01482858
First Posted: December 1, 2011
Last Update Posted: December 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Amorphical Ltd.
  Purpose
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.

Condition Intervention Phase
Osteoporosis Dietary Supplement: Gastrolith Other: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Amorphical Ltd.:

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

Estimated Enrollment: 80
Study Start Date: December 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01482858


Contacts
Contact: Galit Shaltiel-Glod, PhD 972 (0)8-6479411- galits@amorphical.com

Locations
Israel
Clalit Health Services - South District Not yet recruiting
Be'er Sheva, Israel
Contact: Pesach Shwartzman, MD    972-(0)8-6477433      
Principal Investigator: Pesach Shwartzman, MD         
Soroka Medical Center Not yet recruiting
Be'er Sheva, Israel
Contact: Pesach Shwartzman, MD    972-(0)8-6477433      
Principal Investigator: Pesach Shwartzman, MD         
Rambam Medical Center Not yet recruiting
Haifa, Israel
Contact: Tsofia Ish-Shalom, MD    972-(0)4-8541533      
Principal Investigator: Tsofia Ish-Shalom, MD         
Hadassah Ein Carem Not yet recruiting
Jerusalem, Israel
Contact: Eliad Davidson, MD    972-(0)2-6776911      
Principal Investigator: Eliad Davidson, MD         
Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel
Contact: Sylvio Brill, MD    972-(0)3-6974581      
Principal Investigator: Sylvio Brill, MD         
Sponsors and Collaborators
Amorphical Ltd.
Investigators
Principal Investigator: Eliad Davidson, MD Hadassah Ein Carem Medical Center, Jerusalem, Israel
  More Information

Responsible Party: Amorphical Ltd.
ClinicalTrials.gov Identifier: NCT01482858     History of Changes
Other Study ID Numbers: AMCS-003
First Submitted: November 29, 2011
First Posted: December 1, 2011
Last Update Posted: December 1, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Osteoporosis
Spinal Fractures
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Spinal Injuries
Back Injuries
Wounds and Injuries
Fractures, Bone
Calcium, Dietary
Analgesics
Calcium Carbonate
Bone Density Conservation Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents