OsteoporosisPhase 3NCT05305183
A Phase III Clinical Study of Minodronate Tablets in Postmenopausal Women With Osteoporosis
A Phase 3 study of Osteoporosis, run by Shandong New Time Pharmaceutical Co., LTD at 1 site in China.
Trial summary
In the randomized, active-controlled, double-blinded, multicenter study, the efficacy and safety of monthly oral minodronate were examined and compared to that of weekly oral alendronate. Read more about this study
- Who is it for?
- Ages 46 to 80 years, women only
- Conditions the study is for
- Osteoporosis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 330 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2022to 31 May 2024
- Phase
- Phase 3
- 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 46 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 46-80 years, menopause for more than 1 year, free to move，Estradiol ≤20pg/mL and follicle stimulating hormone ≥40IU/L in patients with simple hysterectomy;
- Body mass index (BMI) is 18.5-30.0kg/m2, including critical value, BMI= weight (kg)/height 2 (m2);
- Based on dual energy X-ray absorption (DXA)Determination, bone density (BMD) determination of lumbar vertebrae L1-L4 (At least 2 consecutive lumbar vertebrae for accurate measurement of BMD ) mean T ≤ -2.5SD, or T≤ -2.5SD on either side of the double hip femoral neck;
- Understand the procedures and methods of this clinical study, voluntarily participate in and sign the informed consent form.
Who cannot join
- Patients with conditions that affect BMD measurement, such as severe scoliosis or any lumbar L1-L4 fracture or hip fracture;
- Patients with secondary osteoporosis;
- Endocrine diseases or other diseases affecting bone metabolism that the investigator considers inappropriate, such as gonads, adrenal glands, primary parathyroid dysfunction, or malformed osteitis (Paget's bone disease), nephrotic rickets, osteomalacia, rheumatoid arthritis, osteogenesis imperfecta , poorly controlled hyperthyroidism or hypothyroidism;
- Patients with serious primary diseases such as cardiovascular, cerebrovascular and hematopoietic system, and mental or nervous system diseases;
- Patients with abnormal blood calcium: serum calcium or serum calcium corrected by albumin ≤2.0mmol/L or ≥2.9mmol/L;
- Parathyroid hormone > 1.5 times the upper limit of normal;
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- Patients with severe gastrointestinal absorption dysfunction such as dysphagia, esophagitis, enteritis or peptic ulcer，crohn's disease and chronic pancreatitis;
- Patients with delayed obstruction of the esophagus, such as narrow or loose esophagus;
- patients has previous or co-existing malignancies (except skin basal cell carcinoma and carcinoma in situ of the cervix, which have been cured for more than 3 years);
- The patient who are deformed, disabled, unable to work or in a critical condition; which difficult to evaluate the effectiveness and safety of drugs accurately ;
- Patients with type 1 diabetes or type 2 diabetes with poor glycemic control and severe acute and chronic complications;
- Patients had received any other investigational drug/device treatment within 3 months prior to enrollment;
- Patients with renal insufficiency or severe renal impairment(Ccr<35mL/min);
- Patients with abnormal liver function (ALT or AST≥2.0 times the upper limit of normal);
- Allergic constitution or allergic to study related drugs (calcium, vitamin D, minodronic acid or similar drugs);
- Hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) positive with HBV-DNA positive, hepatitis C virus (HCV) antibody positive with HCV-RNA positive, human immunodeficiency virus (HIV) positive, syphilis antibody positive;
- The patients has previous or co-existing osteomyelitis or osteonecrosis of the mandible, the patients have dental surgery such as tooth extraction during the first 2 months of enrollment or during the trial;
- The patients with a history of drug abuse or alcohol abuse within 6 months prior to enrollment;
- The patients used the following drugs before enrollment: used oral bisphosphonate more than 3 months within 1 year or the cumulative use of oral bisphosphonate more than 1 year; used desomumab within 1 year;used intravenous bisphosphonate within the past 5 years;patients daily used systemic corticosteroid equivalent to prednisone > 5mg more than 14 days within 2 months (local external use is excluded) ;used calcitonin or active vitamin D complex within 6 weeks; used selective estrogen receptor modulators or estrogen replacement therapy for more than 1 month within 6 months;Qianggu capsule, total flavone of Epimedium, Jintiange capsule, Xianling Gubao capsule, Qigu capsule, Gushukang capsule and Zuogui pill were used for more than 3 months in 6 months;
- Other patients that the investigator believes are not suitable for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site
Shandong New Time Pharmaceutical Co., LTD
Shandong
Zhang jian xiang
Zhang zhen lin, doctor
About this study
Official title: A Randomized, Double-blinded, Active-controlled, Multicentered Phase III Trial to Assess the Efficacy and Safety of Minodronate Tablets in Postmenopausal Women With Osteoporosis
In the randomized, active-controlled, double-blinded, multicenter study, the efficacy and safety of monthly oral minodronate were examined and compared to that of weekly oral alendronate.
- Conditions
- Osteoporosis
- Being tested
- Minodronate Tablets and Alendronate Sodium Tablets-matching placebo;Alendronate Sodium Tablets and Minodronate Tablets -matching placebo
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minodronate Tablets and Alendronate Sodium Tablets-matching placebo;Alendronate Sodium Tablets and Minodronate Tablets -matching placeboDrug
all subjects will receive Calcium Carbonate and Vitamin D3 Tablets as basic medication.
| Study group | Role | What they receive |
|---|---|---|
| Alendronate Sodium Tablets and Minodronate Tablets -matching placebo | Active comparator | subjects received 70 mg alendronate sodium tablet weekly and a minodronate tablet matching placebo monthly for 48 weeks. Receives: Drug: Minodronate Tablets and Alendronate Sodium Tablets-matching placebo;Alendronate Sodium Tablets and Minodronate Tablets -matching placebo |
| Minodronate Tablets and Alendronate Sodium Tablets-matching placebo | Experimental | subjects received 50mg minodronate tablets monthly and an alendronate sodium tablets -matching placebo weekly for 48 weeks. Receives: Drug: Minodronate Tablets and Alendronate Sodium Tablets-matching placebo;Alendronate Sodium Tablets and Minodronate Tablets -matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The average rate of bone mineral density change of lumbar spine (L1-L4 ) was compared between 48 weeks after administration and before administration .the group of minodronate were examined and compared to that of alendronate.
Measured: 48 weeks
Secondary outcomes (3)
The average rate of bone mineral density change of lumbar spine (L1-L4 ) was compared between 24 weeks after administration and before administration .
Measured: 24weeks
The change rate of bone turnover markers from baseline to 12、24、48 weeks, including serum type I collagen amino terminal peptide(P1NP) and serum C-terminal telopeptide of type 1 collagen (S-CTX ).
Measured: 12、24、48 weeks,
the change rates of bone density at the femoral neck and the whole hip from baseline to the end of 24 and 48 weeks.
Measured: 24、48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start31 May 2022 (estimated)
- Primary completion31 May 2023 (estimated)
- Study completion31 May 2024 (estimated)
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.
- More trials run by Shandong New Time Pharmaceutical Co., LTDThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305183
- Sponsor's protocol ID
- NTP-MNLS-T-Ⅲ
- Status last verified
- Mar 2022
- First submitted
- 22 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded, Active-controlled, Multicentered Phase III Trial to Assess the Efficacy and Safety of Minodronate Tablets in Postmenopausal Women With Osteoporosis
- ClinicalTrials.gov ID
- NCT05305183
- Acronym / sponsor ID
- NTP-MNLS-T-Ⅲ
- Conditions
- Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Shandong New Time Pharmaceutical Co., LTDIndustry (pharma, biotech, devices)
- Study start
- 31 May 2022 (estimated)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 31 Mar 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.
In the randomized, active-controlled, double-blinded, multicenter study, the efficacy and safety of monthly oral minodronate were examined and compared to that of weekly oral alendronate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alendronate Sodium Tablets and Minodronate Tablets -matching placebo | Active comparator | Drug: Minodronate Tablets and Alendronate Sodium Tablets-matching placebo;Alendronate Sodium Tablets and Minodronate Tablets -matching placebosubjects received 70 mg alendronate sodium tablet weekly and a minodronate tablet matching placebo monthly for 48 weeks. |
| Minodronate Tablets and Alendronate Sodium Tablets-matching placebo | Experimental | Drug: Minodronate Tablets and Alendronate Sodium Tablets-matching placebo;Alendronate Sodium Tablets and Minodronate Tablets -matching placebosubjects received 50mg minodronate tablets monthly and an alendronate sodium tablets -matching placebo weekly for 48 weeks. |
Who may qualify
- Ages
- 46 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women aged 46-80 years, menopause for more than 1 year, free to move，Estradiol ≤20pg/mL and follicle stimulating hormone ≥40IU/L in patients with simple hysterectomy;
- Body mass index (BMI) is 18.5-30.0kg/m2, including critical value, BMI= weight (kg)/height 2 (m2);
- Based on dual energy X-ray absorption (DXA)Determination, bone density (BMD) determination of lumbar vertebrae L1-L4 (At least 2 consecutive lumbar vertebrae for accurate measurement of BMD ) mean T ≤ -2.5SD, or T≤ -2.5SD on either side of the double hip femoral neck;
- Understand the procedures and methods of this clinical study, voluntarily participate in and sign the informed consent form.
Key exclusion criteria (20 listed)
- Patients with conditions that affect BMD measurement, such as severe scoliosis or any lumbar L1-L4 fracture or hip fracture;
- Patients with secondary osteoporosis;
- Endocrine diseases or other diseases affecting bone metabolism that the investigator considers inappropriate, such as gonads, adrenal glands, primary parathyroid dysfunction, or malformed osteitis (Paget's bone disease), nephrotic rickets, osteomalacia, rheumatoid arthritis, osteogenesis imperfecta , poorly controlled hyperthyroidism or hypothyroidism;
- Patients with serious primary diseases such as cardiovascular, cerebrovascular and hematopoietic system, and mental or nervous system diseases;
- Patients with abnormal blood calcium: serum calcium or serum calcium corrected by albumin ≤2.0mmol/L or ≥2.9mmol/L;
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 |
|---|---|---|
| Minodronate Tablets and Alendronate Sodium Tablets-matching placebo;Alendronate Sodium Tablets and Minodronate Tablets -matching placeboall subjects will receive Calcium Carbonate and Vitamin D3 Tablets as basic medication. | Drug | Alendronate Sodium Tablets and Minodronate Tablets -matching placebo, Minodronate Tablets and Alendronate Sodium Tablets-matching placebo |
Primary outcome
The average rate of bone mineral density change of lumbar spine (L1-L4 ) was compared between 48 weeks after administration and before administration .the group of minodronate were examined and compared to that of alendronate.
Time frame: 48 weeks
3 secondary outcomes
The average rate of bone mineral density change of lumbar spine (L1-L4 ) was compared between 24 weeks after administration and before administration .
Time frame: 24weeks
The change rate of bone turnover markers from baseline to 12、24、48 weeks, including serum type I collagen amino terminal peptide(P1NP) and serum C-terminal telopeptide of type 1 collagen (S-CTX ).
Time frame: 12、24、48 weeks,
the change rates of bone density at the femoral neck and the whole hip from baseline to the end of 24 and 48 weeks.
Time frame: 24、48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Osteoporosis, run by Shandong New Time Pharmaceutical Co., LTD 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 4 inclusion and 20 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 31 Mar 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Zhang jian xiang (0539-8330397, jianxiangzhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The average rate of bone mineral density change of lumbar spine (L1-L4 ) was compared between 48 weeks after administration and before administration .the group of minodronate were examined and compared to that of alendronate. (time frame: 48 weeks). 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 31 Mar 2022.