Chronic Low Back PainPhase 1/2NCT01210599
A Pilot Trial of IV Pamidronate for Low Back Pain
A Phase 1/2 study testing Pamidronate in people with Chronic Low Back Pain, run by Pappagallo, Marco, M.D. at 1 site in United States.
Trial summary
INTRODUCTION Pamidronate and other bisphosphonates (bisph) have an anti-nociceptive effect in animals. In humans, IV pamidronate is analgesic in patients affected by numerous painful conditions, including cancer bone pain, complex regional pain syndrome (CRPS), ankylosing spondylitis, and rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Pamidronate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Oct 2009
- Phase
- Phase 1/2
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females 21 years of age or older Non-specific, mechanical predominantly axial CLBP (subjects with below the knee pain included when the LBP component was 50% or more than the overall pain component)
- Pain for at least 3 months, with a minimum average daily pain score of 4 on a 0-10 NRS MRI evidence of disc degeneration and changes consistent with the diagnosis of degenerative disc disease or spondylotic disease of the spine.
Who cannot join
- Prior back surgery, compression fracture(s), cancer as possible cause of back pain Clinically relevant radiculopathic pain,
- MRI evidence of frank DISK HERNIATION or any other abnormality or pathology regarded as the probable cause of the patient's pain.
- Defect or fracture of a pars interarticularis, spondylolisthesis with greater than 4 mm of misalignment Having a glomerular filtration rate (GFR) less than 60 ml/min/1.73m 2 .
- Hypocalcemia, significant cardiac, hematological, renal, hepatic, metabolic, endocrinological disease
- Being pregnant or nursing
- Receiving Worker's Compensation, having a pending legal claim
Show all 9Show fewer
- Weighing less than 45 kg
- Subjects who score 26 and above on the Beck Depression Inventory
- Prior pamidronate treatment patients who in the opinion of the study physician have poor oral hygiene, do not have regular dental care, had a tooth extraction or another invasive dental procedure within 3 months prior to study enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Mount Sinai Medical Center
New York, New York, 10029
About this study
Official title: A Pilot Trial of Intravenous Pamidronate for Low Back Pain
INTRODUCTION Pamidronate and other bisphosphonates (bisph) have an anti-nociceptive effect in animals. In humans, IV pamidronate is analgesic in patients affected by numerous painful conditions, including cancer bone pain, complex regional pain syndrome (CRPS), ankylosing spondylitis, and rheumatoid arthritis. The investigators have explored the effect of IV pamidronate in the management of chronic low back pain (CLBP), a worldwide public health problem in terms of lost workdays, treatment costs, and suffering.
The study was a randomized, double blind, dose-escalation trial of IV pamidronate. Study participants were divided among four study phases. Each group received IV placebo or escalating doses of IV pamidronate.
Read more
STUDY DESIGN A phase I-II, randomized, double-blind, placebo controlled, dose finding study for the treatment of patients with CLBP with IV pamidronate. The study was first conducted at Beth Israel Medical Center, NY for the first two groups, and was completed at Mount Sinai Medical Center , NY for the remaining groups.
PRIMARY OBJECTIVES The intent of this pilot study was to determine the optimal IV pamidronate treatment protocol for CLBP in a Phase III trial. Primary study aims were safety and average daily pain. Subjects used an electronic diary (LOGPAD) to record their daily adverse events (AEs) and their baseline and post-treatment average pain on the 0-10 numerical rating scale (NRS).
STATISTICAL ANALYSES All the analysis were performed on an intention-to-treat basis. Primary outcomes are LOGPAD change in pain severity and whether a patient was a responder (pain score dropped ≥2 points or ≥30%). Because there was no statistical difference in these two outcomes among the 4 placebo groups, all placebo patients were combined (Comb PL) in the subsequent analyses. Primary analytic tool was mixed model for repeated measures (MMRM), assuming autoregressive covariance structure (LOGPAD pain and Brief Pain Inventory - BPI interferences), and Generalized Estimating Equation (GEE) model for categorical outcomes (Response rates and Patient Global Impression of Change - PGIC). The main objective was to assess whether the changes in outcome from baseline or the response rates were the same across the study phases, while adjusting for baseline values and time effect. Least square means were contrasted. Interaction between time and study phases were also tested to see if the treatment effect is a function of time. Fisher's exact tests or ANOVA (Kruskal-Wallis) tests were performed for cross-sectional group comparison, including baseline.
Read the detailed description
INCLUSION STUDY CRITERIA Males and females 21 years of age or older Non-specific, mechanical predominantly axial CLBP (subjects with below the knee pain included when the LBP component was 50% or more than the overall pain component) Pain for at least 3 months, with a minimum average daily pain score of 4 on a 0-10 NRS MRI evidence of disc degeneration and changes consistent with the diagnosis of degenerative disc disease or spondylotic disease of the spine.
EXCLUSION STUDY CRITERIA Prior back surgery, compression fracture(s), cancer as possible cause of back pain Clinically relevant radiculopathic pain, MRI evidence of frank DISK HERNIATION or any other abnormality or pathology regarded as the probable cause of the patient's pain.
Defect or fracture of a pars interarticularis, spondylolisthesis with greater than 4 mm of misalignment Having a glomerular filtration rate (GFR) less than 60 ml/min/1.73m 2 . Hypocalcemia, significant cardiac, hematological, renal, hepatic, metabolic, endocrinological disease Being pregnant or nursing Receiving Worker's Compensation, having a pending legal claim Weighing less than 45 kg Subjects who score 26 and above on the Beck Depression Inventory Prior pamidronate treatment patients who in the opinion of the study physician have poor oral hygiene, do not have regular dental care, had a tooth extraction or another invasive dental procedure within 3 months prior to study enrollment
- Conditions
- Chronic Low Back Pain
- Being tested
- Pamidronate
- Keywords
- Back Pain, Bisphosphonate, Pamidronate, Bone Pain
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PamidronateDrug
The study was a randomized, double blind, dose-escalation trial of IV pamidronate. Study participants were divided among four study phases. Each group received IV placebo or escalating doses of IV pamidronate of 30mg, 60mg, 90mg and 180mg.
| Study group | Role | What they receive |
|---|---|---|
| IV infusion of pamidronate vs placebo | Experimental | Not described Receives: Drug: Pamidronate |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2010 (estimated)
- Study startApr 2004
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pappagallo, Marco, M.D.
- Investigators
- Marco Pappagallo, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01210599
- Sponsor's protocol ID
- 06-0782
- Status last verified
- Sep 2010
- First submitted
- 27 Sep 2010
- Last updated
- 13 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Intravenous Pamidronate for Low Back Pain
- ClinicalTrials.gov ID
- NCT01210599
- Acronym / sponsor ID
- 06-0782
- Conditions
- Chronic Low Back Pain
- Keywords
- Back Pain, Bisphosphonate, Pamidronate, Bone Pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Pappagallo, Marco, M.D.
- Study start
- Apr 2004
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 28 Sep 2010 (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.
INTRODUCTION Pamidronate and other bisphosphonates (bisph) have an anti-nociceptive effect in animals. In humans, IV pamidronate is analgesic in patients affected by numerous painful conditions, including cancer bone pain, complex regional pain syndrome (CRPS), ankylosing spondylitis, and rheumatoid arthritis. The investigators have explored the effect of IV pamidronate in the management of chronic low back pain (CLBP), a worldwide public health problem in terms of lost workdays, treatment costs, and suffering.
The study was a randomized, double blind, dose-escalation trial of IV pamidronate. Study participants were divided among four study phases. Each group received IV placebo or escalating doses of IV pamidronate.
STUDY DESIGN A phase I-II, randomized, double-blind, placebo controlled, dose finding study for the treatment of patients with CLBP with IV pamidronate. The study was first conducted at Beth Israel Medical Center, NY for the first two groups, and was completed at Mount Sinai Medical Center , NY for the remaining groups.
PRIMARY OBJECTIVES The intent of this pilot study was to determine the optimal IV pamidronate treatment protocol for CLBP in a Phase III trial. Primary study aims were safety and average daily pain. Subjects used an electronic diary (LOGPAD) to record their daily adverse events (AEs) and their baseline and post-treatment average pain on the 0-10 numerical rating scale (NRS).
STATISTICAL ANALYSES All the analysis were performed on an intention-to-treat basis. Primary outcomes are LOGPAD change in pain severity and whether a patient was a responder (pain score dropped ≥2 points or ≥30%). Because there was no statistical difference in these two outcomes among the 4 placebo groups, all placebo patients were combined (Comb PL) in the subsequent analyses. Primary analytic tool was mixed model for repeated measures (MMRM), assuming autoregressive covariance structure (LOGPAD pain and Brief Pain Inventory - BPI interferences), and Generalized Estimating Equation (GEE) model for categorical outcomes (Response rates and Patient Global Impression of Change - PGIC). The main objective was to assess whether the changes in outcome from baseline or the response rates were the same across the study phases, while adjusting for baseline values and time effect. Least square means were contrasted. Interaction between time and study phases were also tested to see if the treatment effect is a function of time. Fisher's exact tests or ANOVA (Kruskal-Wallis) tests were performed for cross-sectional group comparison, including baseline.
Detailed description
INCLUSION STUDY CRITERIA Males and females 21 years of age or older Non-specific, mechanical predominantly axial CLBP (subjects with below the knee pain included when the LBP component was 50% or more than the overall pain component) Pain for at least 3 months, with a minimum average daily pain score of 4 on a 0-10 NRS MRI evidence of disc degeneration and changes consistent with the diagnosis of degenerative disc disease or spondylotic disease of the spine.
EXCLUSION STUDY CRITERIA Prior back surgery, compression fracture(s), cancer as possible cause of back pain Clinically relevant radiculopathic pain, MRI evidence of frank DISK HERNIATION or any other abnormality or pathology regarded as the probable cause of the patient's pain.
Defect or fracture of a pars interarticularis, spondylolisthesis with greater than 4 mm of misalignment Having a glomerular filtration rate (GFR) less than 60 ml/min/1.73m 2 . Hypocalcemia, significant cardiac, hematological, renal, hepatic, metabolic, endocrinological disease Being pregnant or nursing Receiving Worker's Compensation, having a pending legal claim Weighing less than 45 kg Subjects who score 26 and above on the Beck Depression Inventory Prior pamidronate treatment patients who in the opinion of the study physician have poor oral hygiene, do not have regular dental care, had a tooth extraction or another invasive dental procedure within 3 months prior to study enrollment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IV infusion of pamidronate vs placebo | Experimental | Drug: Pamidronate |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males and females 21 years of age or older Non-specific, mechanical predominantly axial CLBP (subjects with below the knee pain included when the LBP component was 50% or more than the overall pain component)
- Pain for at least 3 months, with a minimum average daily pain score of 4 on a 0-10 NRS MRI evidence of disc degeneration and changes consistent with the diagnosis of degenerative disc disease or spondylotic disease of the spine.
Key exclusion criteria (9 listed)
- Prior back surgery, compression fracture(s), cancer as possible cause of back pain Clinically relevant radiculopathic pain,
- MRI evidence of frank DISK HERNIATION or any other abnormality or pathology regarded as the probable cause of the patient's pain.
- Defect or fracture of a pars interarticularis, spondylolisthesis with greater than 4 mm of misalignment Having a glomerular filtration rate (GFR) less than 60 ml/min/1.73m 2 .
- Hypocalcemia, significant cardiac, hematological, renal, hepatic, metabolic, endocrinological disease
- Being pregnant or nursing
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 |
|---|---|---|
| PamidronateThe study was a randomized, double blind, dose-escalation trial of IV pamidronate. Study participants were divided among four study phases. Each group received IV placebo or escalating doses of IV pamidronate of 30mg, 60mg, 90mg and 180mg. | Drug | IV infusion of pamidronate vs placebo |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2010.
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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.
Marco Pappagallo, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pamidronate in people with Chronic Low Back Pain, run by Pappagallo, Marco, M.D. at 1 site in United States.
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 2 inclusion and 9 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: finished, as of the sponsor's last update on 13 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 13 Oct 2010.