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.

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.

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.

In this study the oral calcium treatments are blinded. The subjects, the investigators and any personnel involved in subjects' assessment, monitoring, analysis and data management will be blinded to the subject formulation assignment except the Sponsor who will be responsible for preparing, dispensing and labeling the investigational product IP. Blinded labels will be affixed to the vials prior to dosing by the un-blinded Sponsor.