Postmenopausal OsteoporosisPhase 4NCT05645289
Efficacy and Safety of Minodronate in Patients With Low Back Pain
A Phase 4 study testing Minodronate and Alendronate in people with Postmenopausal Osteoporosis, run by Peking University Third Hospital at 1 site in China.
Trial summary
This study will provide objective evidence for the efficiency and safety of minodronate in the treatment of postmenopausal osteoporosis with low back pain protocol. Furthermore, it will be helpful to evaluate the quantitative relationship between bone metabolic markers (BTM) and bone mineral density (BMD) in patients… Read more about this study
- Who is it for?
- Ages 55 to 95 years, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- Minodronate and Alendronate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Apr 2024
- Phase
- Phase 4
- 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 55 to 95 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese postmenopausal patients with a diagnosis of OP;
- Patients with low back pain of at least 3 months and a VAS score ≥30;
- The value of lumbar L1-4 or total hip bone density measured by DXA is < -2.5;
- Serum 25-hydroxyvitamin D (25-OHD) concentration ≥20 ng/mL;
- Patients with full capacity for civil conduct and understanding of the research process and methods voluntarily participated in this study and signed the informed consent form.
Who cannot join
- Patient who are allergic to minodronate, alendronate, or other bisphosphonate drug or any other component of the drug under evaluation;
- Patients with a diagnosis of secondary OP;
- The following drugs affecting bone metabolism were used before the screening:
- Received injections of bisphosphonate and denosumab within 3 years; Received oral bisphosphonate, parathyroid hormones or analogues, strontium, or fluoride within 6 months; Received glucocorticoids, steroids, immunosuppressants, calcitonin, calcitriol or its analogues, thiazide diuretics, and ng-acting oestrogen/progesterone replacement therapy within 3 months;
- Patients with a diagnosis of diseases affecting bone metabolism (e.g., osteogenesis imperfecta, malignancy, progressive diaphyseal dysplasia, Paget's disease, rheumatoid arthritis, osteosclerosis, osteoporosis with a slipped disc and spinal stenosis, and liver and kidney failure);
- Patients are participating or have participated in an investigational drug study within 3 months before signing the informed consent form;
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- Patients under 75 years old with a creatinine clearance rate < 60 mL/min and those > 75 years old with a creatinine clearance rate < 45 mL/min;
- Serum calcium levels < 2.0 mmol/L (8 mg/dL) or > 2.7 mmol/L (11.0 mg/dL);
- Patients with fever, severe infection, severe trauma, or major surgery within 30 days;
- Patients with a QTc interval of > 480 ms;
- Patients are undergoing or planning to undergo invasive dental treatment;
- Smoking history in the past six months;
- Patients with a history of alcohol abuse (> 15 g of alcohol per day, equivalent to 350 mL of beer or 150 mL of wine, more than twice per week) and drug abuse;
- Patients with a prior history of cerebral infarction, ischaemic or haemorrhagic stroke;
- Patients with implants and/or fractures in the lumbar spine or hip that interfere with BMD testing;
- Received pain relievers (e.g., nonsteroidal anti-inflammatory drugs, central analgesics) or life interventions to relieve pain within 1 week before screening;
Trial locations and contacts
1 site in 1 country.
Chunli Song, Pro. contact
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Huan Wang, Ms., 18251825313 ext. +86, wh18324178960@163.com
Chunli Song, Pro.
About this study
Official title: Efficacy and Safety of Minodronate in the Treatment of Postmenopausal Osteoporosis With Low Back Pain: a Single-centre and Randomized Controlled Trial
This study will provide objective evidence for the efficiency and safety of minodronate in the treatment of postmenopausal osteoporosis with low back pain protocol. Furthermore, it will be helpful to evaluate the quantitative relationship between bone metabolic markers (BTM) and bone mineral density (BMD) in patients with osteoporosis under different ages.
Read the detailed description
The study is a randomized, parallel controlled clinical trial in Chinese postmenopausal OP patients receiving minodronate or alendronate. Minodronate will be administered once daily for 12 weeks, and alendronate will be administered once daily for 12 weeks. This study is divided into two stages: the first stage is 12 weeks, and at the end of the first stage, the results of patients' back pain and gastrointestinal adverse reactions will be summarized; the second stage is 12 weeks, and the pharmacokinetic and pharmacodynamic characteristics of patients will be summarized at the end of the second stage. The VAS score in this study rangs from 0-100 mm. During the screening, the patient's past pain relief methods, such as pain medication or the way of life intervention will be recorded. The use of the above methods during the patients' treatment will be prohibited to prevent interference with the results of the clinical trials. During the treatment, if patients experience sudden aggravation of low back pain, the VAS score is more than 70, and the patients could not bear the pain, a rescue drug (acetaminophen) will be used uniformly to relieve the pain. Throughout the trial, a total of 5 follow-up visits will be planned. The VAS score, PK\&PD sampling, BMD evaluation, and Izumo scale score will be calculated.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- Minodronate, Alendronate
- Keywords
- minodronate, low back pain, adverse reactions, pharmacokinetic, pharmacodynamic
- Medical subject headings
- Osteoporosis, Postmenopausal, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinodronateDrug
Also called Difumi
The minodronate group: The group will include thirty-six patients. Patients will take 1 mg of minodronate tablets orally with 200 mL of water in the morning. They can not lie flat for at least 30 minutes after taking the tablets, and they can not eat anything except water for at least 30 minutes after taking the tablets once a day for 12 weeks, for a total of 84 times.
AlendronateDrug
Also called Fushanmei
The alendronate group: A total of 36 patients will be treated with alendronate. Patients will be orally given 10-mg alendronate tablets daily and 200 mL of water in the morning. They could not lie down and eat anything except water for at least 30 minutes after taking the tablets. The treatment lasted for 12 weeks, corresponding to a total of 84 doses.
| Study group | Role | What they receive |
|---|---|---|
| minodronate | Experimental | Patients will take 1 mg of minodronate tablets orally in the morning. Receives: Drug: Minodronate |
| alendronate | Active comparator | Patients will be orally given 10 mg alendronate tablets daily in the morning. Receives: Drug: Alendronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time for a 10 point decrease in the VAS score within 24 weeks
The VAS scores were measured daily within 24 weeks. Back pain was evaluated using a 100-mm VAS score ( 0 = no pain, 100 = worst pain possible) after treatment, where the patients recorded their pain on the VAS by themselves everyday.
Measured: up to 24 weeks
Secondary outcomes (11)
Concentration in plasma of minodronate and alendronate on the first day before administration
Minodronate and alendronate concentration in plasma
Measured: on the first day before administration
Concentration in plasma of minodronate and alendronate on the 8th week after administration
Minodronate and alendronate concentration in plasma
Measured: on the 8th week after administration
Concentration in plasma of minodronate and alendronate on the 12th week after administration
Minodronate and alendronate concentration in plasma
Measured: on the 12th week after administration
Concentration in plasma of minodronate and alendronate on the 24th week after administration
Minodronate and alendronate concentration in plasma
Measured: on the 24th week after administration
Maximum concentration of minodronate and alendronate within 24 weeks
The observed maximum concentration following administration (Cmax) in plasma after minodronate and alendronate administration.
Measured: 0-24 weeks
AUC of minodronate and alendronate within 24 weeks
The area under the concentration-time curve (AUC) in plasma after minodronate and alendronate administration.
Measured: 0-24 weeks
Apparent clearance of minodronate and alendronate within 24 weeks
The apparent clearance (CL/F) of minodronate and alendronate after administration.
Measured: 0-24 weeks
The pharmacodynamic of minodronate and alendronate on the first day before administration
Assessment of bone mineral density at the lumbar spine, and total hip
Measured: on the first day before administration
The pharmacodynamic of minodronate and alendronate on the 12th week after administration
Assessment of bone mineral density at the lumbar spine, and total hip
Measured: on the12th week after administration
The pharmacodynamic of minodronate and alendronate on the 24th week after administration
Assessment of bone mineral density at the lumbar spine, and total hip
Measured: on the 24th week after administration
The incidence of upper gastrointestinal symptoms
The incidence of upper gastrointestinal symptom after medication administration
Measured: 0-24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal OsteoporosisStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chunli Song, Pro., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645289
- Sponsor's protocol ID
- M2022465
- Status last verified
- Nov 2022
- First submitted
- 18 Nov 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yoshioka T, Okimoto N, Okamoto K, Sakai A. A comparative study of the effects of daily minodronate and weekly alendronate on upper gastrointestinal symptoms, bone resorption, and back pain in postmenopausal osteoporosis patients. J Bone Miner Metab. 2013 Mar;31(2):153-60. doi: 10.1007/s00774-012-0393-x. Epub 2012 Oct 19.
PubMed 23076293Wang H, Huang J, Tao L, Liu D, Song C. Efficacy and safety of minodronate in the treatment of postmenopausal osteoporosis with low back pain: a single-centre, randomized and open-label controlled trial. Trials. 2024 Aug 13;25(1):534. doi: 10.1186/s13063-024-08364-7.
PubMed 39135126
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Minodronate in the Treatment of Postmenopausal Osteoporosis With Low Back Pain: a Single-centre and Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05645289
- Acronym / sponsor ID
- M2022465
- Conditions
- Postmenopausal Osteoporosis
- Keywords
- minodronate, low back pain, adverse reactions, pharmacokinetic, pharmacodynamic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 9 Dec 2022 (actual)
- 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 will provide objective evidence for the efficiency and safety of minodronate in the treatment of postmenopausal osteoporosis with low back pain protocol. Furthermore, it will be helpful to evaluate the quantitative relationship between bone metabolic markers (BTM) and bone mineral density (BMD) in patients with osteoporosis under different ages.
Detailed description
The study is a randomized, parallel controlled clinical trial in Chinese postmenopausal OP patients receiving minodronate or alendronate. Minodronate will be administered once daily for 12 weeks, and alendronate will be administered once daily for 12 weeks. This study is divided into two stages: the first stage is 12 weeks, and at the end of the first stage, the results of patients' back pain and gastrointestinal adverse reactions will be summarized; the second stage is 12 weeks, and the pharmacokinetic and pharmacodynamic characteristics of patients will be summarized at the end of the second stage. The VAS score in this study rangs from 0-100 mm. During the screening, the patient's past pain relief methods, such as pain medication or the way of life intervention will be recorded. The use of the above methods during the patients' treatment will be prohibited to prevent interference with the results of the clinical trials. During the treatment, if patients experience sudden aggravation of low back pain, the VAS score is more than 70, and the patients could not bear the pain, a rescue drug (acetaminophen) will be used uniformly to relieve the pain. Throughout the trial, a total of 5 follow-up visits will be planned. The VAS score, PK\&PD sampling, BMD evaluation, and Izumo scale score will be calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| minodronate | Experimental | Drug: MinodronatePatients will take 1 mg of minodronate tablets orally in the morning. |
| alendronate | Active comparator | Drug: AlendronatePatients will be orally given 10 mg alendronate tablets daily in the morning. |
Who may qualify
- Ages
- 55 to 95 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chinese postmenopausal patients with a diagnosis of OP;
- Patients with low back pain of at least 3 months and a VAS score ≥30;
- The value of lumbar L1-4 or total hip bone density measured by DXA is < -2.5;
- Serum 25-hydroxyvitamin D (25-OHD) concentration ≥20 ng/mL;
- Patients with full capacity for civil conduct and understanding of the research process and methods voluntarily participated in this study and signed the informed consent form.
Key exclusion criteria (16 listed)
- Patient who are allergic to minodronate, alendronate, or other bisphosphonate drug or any other component of the drug under evaluation;
- Patients with a diagnosis of secondary OP;
- The following drugs affecting bone metabolism were used before the screening:
- Received injections of bisphosphonate and denosumab within 3 years; Received oral bisphosphonate, parathyroid hormones or analogues, strontium, or fluoride within 6 months; Received glucocorticoids, steroids, immunosuppressants, calcitonin, calcitriol or its analogues, thiazide diuretics, and ng-acting oestrogen/progesterone replacement therapy within 3 months;
- Patients with a diagnosis of diseases affecting bone metabolism (e.g., osteogenesis imperfecta, malignancy, progressive diaphyseal dysplasia, Paget's disease, rheumatoid arthritis, osteosclerosis, osteoporosis with a slipped disc and spinal stenosis, and liver and kidney failure);
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 |
|---|---|---|
| MinodronateAlso: DifumiThe minodronate group: The group will include thirty-six patients. Patients will take 1 mg of minodronate tablets orally with 200 mL of water in the morning. They can not lie flat for at least 30 minutes after taking the tablets, and they can not eat anything except water for at least 30 minutes after taking the tablets once a day for 12 weeks, for a total of 84 times. | Drug | minodronate |
| AlendronateAlso: FushanmeiThe alendronate group: A total of 36 patients will be treated with alendronate. Patients will be orally given 10-mg alendronate tablets daily and 200 mL of water in the morning. They could not lie down and eat anything except water for at least 30 minutes after taking the tablets. The treatment lasted for 12 weeks, corresponding to a total of 84 doses. | Drug | alendronate |
Primary outcome
The time for a 10 point decrease in the VAS score within 24 weeks
Time frame: up to 24 weeks
The VAS scores were measured daily within 24 weeks. Back pain was evaluated using a 100-mm VAS score ( 0 = no pain, 100 = worst pain possible) after treatment, where the patients recorded their pain on the VAS by themselves everyday.
11 secondary outcomes
Concentration in plasma of minodronate and alendronate on the first day before administration
Time frame: on the first day before administration
Concentration in plasma of minodronate and alendronate on the 8th week after administration
Time frame: on the 8th week after administration
Concentration in plasma of minodronate and alendronate on the 12th week after administration
Time frame: on the 12th week after administration
Concentration in plasma of minodronate and alendronate on the 24th week after administration
Time frame: on the 24th week after administration
Maximum concentration of minodronate and alendronate within 24 weeks
Time frame: 0-24 weeks
AUC of minodronate and alendronate within 24 weeks
Time frame: 0-24 weeks
Apparent clearance of minodronate and alendronate within 24 weeks
Time frame: 0-24 weeks
The pharmacodynamic of minodronate and alendronate on the first day before administration
Time frame: on the first day before administration
The pharmacodynamic of minodronate and alendronate on the 12th week after administration
Time frame: on the12th week after administration
The pharmacodynamic of minodronate and alendronate on the 24th week after administration
Time frame: on the 24th week after administration
The incidence of upper gastrointestinal symptoms
Time frame: 0-24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Background: PubMed 23076293Yoshioka T, Okimoto N, Okamoto K, Sakai A. A comparative study of the effects of daily minodronate and weekly alendronate on upper gastrointestinal symptoms, bone resorption, and back pain in postmenopausal osteoporosis patients. J Bone Miner Metab. 2013 Mar;31(2):153-60. doi: 10.1007/s00774-012-0393-x. Epub 2012 Oct 19.
- Derived from this study: PubMed 39135126Wang H, Huang J, Tao L, Liu D, Song C. Efficacy and safety of minodronate in the treatment of postmenopausal osteoporosis with low back pain: a single-centre, randomized and open-label controlled trial. Trials. 2024 Aug 13;25(1):534. doi: 10.1186/s13063-024-08364-7.
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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.
Chunli Song, Pro. contact
Chunli Song, Pro. principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Minodronate and Alendronate in people with Postmenopausal Osteoporosis, run by Peking University Third Hospital at 1 site in China.
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 5 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 9 Dec 2022. 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 China. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huan Wang, Ms. (18251825313 ext. +86, wh18324178960@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time for a 10 point decrease in the VAS score within 24 weeks (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05645289, which also lists 2 linked publications.
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 9 Dec 2022.