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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Osteoporosis

Intervention / Treatment
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* Dietary Supplement: Gastrolith
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gastrolith<br>Gelatin capsules, each containing 500 mg of GASP (comprised of 125 ±5 mg elemental calcium) for oral use. | Dietary Supplement: Gastrolith<br>* Gelatin capsules, each containing 500 mg of GASP (comprised of 125 ±5 mg elemental calcium) for oral use.<br>|
| Placebo Comparator: Placebo<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of pain assessed by change in NRS from baseline to end of the trial |  | from baseline to end of the trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |