Trial | NCT01482858  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    80
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 Started
Dec 31
2011
Primary Completion
Jul 31
2012
Anticipated
Study Completion
Aug 31
2012
Anticipated
Last Update
Dec 01
2011
Estimate

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

Gastrolith Experimental

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

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

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.
No Results Posted