---
title: Analgesic Effects of the Gastrolith, in Osteoporotic Patients Suffering From Recent Skeletal Pain Caused by Vertebral Fractures
nct_id: NCT01482858
overall_status: WITHDRAWN
phase: NA
sponsor: Amorphical Ltd.
study_type: INTERVENTIONAL
primary_condition: Osteoporosis
countries: Israel
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01482858.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01482858"
ct_last_update_post_date: 2024-02-28
last_seen_at: "2026-05-12T07:31:18.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Analgesic Effects of the Gastrolith, in Osteoporotic Patients Suffering From Recent Skeletal Pain Caused by Vertebral Fractures

**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

**NCT ID:** [NCT01482858](https://clinicaltrials.gov/study/NCT01482858)

## Key Facts

- **Status:** WITHDRAWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 0
- **Lead Sponsor:** Amorphical Ltd.
- **Conditions:** Osteoporosis
- **Start Date:** 2011-12
- **Completion Date:** 2012-08
- **CT.gov Last Update:** 2024-02-28

## Brief Summary

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.

## Detailed 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **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

## Interventions

- **Gastrolith** (DIETARY_SUPPLEMENT) — Gelatin capsules, each containing 500 mg of GASP (comprised of 125 ±5 mg elemental calcium) for oral use.
- **Placebo** (OTHER) — 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

## Primary Outcomes

- **Reduction of pain assessed by change in NRS from baseline to end of the trial** _(time frame: from baseline to end of the trial)_ — • Change from baseline to end-of-trial on NRS during movement (scale of 0 to 10) computed as follows.

NRSchange = NRS42 - NRS0 NRS42 - NRS score at day 42 (end-of-trial) NRS0 - NRS score at day 0 (baseline)

## Secondary Outcomes

- **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.)_

## Locations (5)

- Clalit Health Services - South District, Beersheba, Israel
- Soroka Medical Center, Beersheba, Israel
- Rambam Medical Center, Haifa, Israel
- Hadassah Ein Carem, Jerusalem, Israel
- Sourasky Medical Center, Tel Aviv, Israel

## Recent Field Changes (last 30 days)

- `design.phases` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.clalit health services - south district|beersheba||israel` — added _(2026-05-12)_
- `locations.soroka medical center|beersheba||israel` — added _(2026-05-12)_
- `locations.rambam medical center|haifa||israel` — added _(2026-05-12)_
- `locations.hadassah ein carem|jerusalem||israel` — added _(2026-05-12)_
- `locations.sourasky medical center|tel aviv||israel` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01482858.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01482858*  
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