OsteoporosisNCT01482858
Analgesic Effects of the Gastrolith, in Osteoporotic Patients Suffering From Recent Skeletal Pain Caused by Vertebral Fractures
A study testing Gastrolith in people with Osteoporosis, run by Amorphical Ltd. at 5 sites in Israel.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Gastrolith
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 5 sitesIsrael
- Study dates
- Dec 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
5 sites in 1 country.
5 sites in 1 country
Israel5 sites
Clalit Health Services - South District
Beersheba
Soroka Medical Center
Beersheba
Rambam Medical Center
Haifa
Hadassah Ein Carem
Jerusalem
Sourasky Medical Center
Tel Aviv
About this study
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
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.
Read the 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.
- Conditions
- Osteoporosis
- Being tested
- Gastrolith, Placebo
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GastrolithDietary supplement
Gelatin capsules, each containing 500 mg of GASP (comprised of 125 ±5 mg elemental calcium) for oral use.
PlaceboOther
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
| Study group | Role | What they receive |
|---|---|---|
| Gastrolith | Experimental | Gelatin capsules, each containing 500 mg of GASP (comprised of 125 ±5 mg elemental calcium) for oral use. Receives: Dietary Supplement: Gastrolith |
| 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of pain assessed by change in NRS 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)
Measured: from baseline to end of the trial
Secondary outcomes (4)
Reduction of pain assessed by change in BPI from baseline to end-of-trial
The BPI uses 0 to 10 numeric rating scales for item rating because of its simplicity, lack of ambiguity and seemed the best to use for cross-linguistic pain measurement. Since pain can be quite variable over a day, the BPI asks subjects to rate their pain at the time of responding to the questionnaire (pain now), and also at its worst, least, and average over the previous week. The ratings can also be made for the last 24 hours.
Measured: baseline to end-of-trial
Reduction of disability assessed by change in ODI from baseline to end-of-trial
Oswestry Low Back Pain Disability Questionnaire - comprises of 10 sections describing the pain and its impact, each scored from 0 to 5 with higher values indicating more severe impact.
Measured: baseline to end-of-trial
Reduction of ASOC assessed by weekly change in analgesic consumption diaries from baseline to end of trial
Analgesic drug consumption will be daily self-recorded by subjects in a diary bearing drug's name and daily dose. The number of tablets taken each day will be noted in each category.
Measured: baseline to end of trial
All adverse events and serious adverse events will be collected and reported
An adverse event is any untoward medical sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of the IPs whether or not considered as IP related. A new condition or the worsening of a pre-existing condition will be considered an AE. All abnormal findings considered to be clinically significant must be recorded as adverse events
Measured: Baseline until four (4) weeks after completion of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionJul 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective randomized double-blind multicenter study evaluating the safety of GASP and its analgesic effect on pain resulting from OCVF following oral administration of GASP vs. placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amorphical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eliad Davidson, MD, Principal investigator, Hadassah Ein Carem Medical Center, Jerusalem, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482858
- Sponsor's protocol ID
- AMCS-003
- Status last verified
- Feb 2024
- First submitted
- 29 Nov 2011
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01482858
- Acronym / sponsor ID
- AMCS-003
- Conditions
- Osteoporosis
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Amorphical Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 1 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This is a prospective randomized double-blind multicenter study evaluating the safety of GASP and its analgesic effect on pain resulting from OCVF following oral administration of GASP vs. placebo.
| Arm | Type | Receives |
|---|---|---|
| Gastrolith | Experimental | Dietary Supplement: GastrolithGelatin capsules, each containing 500 mg of GASP (comprised of 125 ±5 mg elemental calcium) for oral use. |
| Placebo | Placebo comparator | Other: PlaceboGelatin 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GastrolithGelatin capsules, each containing 500 mg of GASP (comprised of 125 ±5 mg elemental calcium) for oral use. | Dietary supplement | Gastrolith |
| PlaceboGelatin 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 |
Primary outcome
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)
4 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eliad Davidson, MD principal investigator
Hadassah Ein Carem Medical Center, Jerusalem, Israel
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastrolith in people with Osteoporosis, run by Amorphical Ltd. at 5 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of pain assessed by change in NRS from baseline to end of the trial (time frame: from baseline to end of the trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.