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

Amorphical

Status: Withdrawn

Conditions: Osteoporosis

Treatments: Dietary Supplement: Gastrolith; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01482858

AMCS-003

Details and patient eligibility

About

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.

Full description

Eighty (80) Osteoporotic subjects with recent reported severe back pain caused by OVCF will be blindly randomized into two groups (n=40 each). One group will receive GASP and the other Placebo.

The analgesic effect of GASP on top of the ASOC will be evaluated using weekly NRS and BPI assessments and three ODI questionnaires. Daily ASOC consumption will be monitored using weekly analgesic consumption diaries.

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Gastrolith

Experimental group

Description:

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

Treatment:

Dietary Supplement: Gastrolith

Placebo

Placebo Comparator group

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

Treatment:

Other: Placebo