Involutional OsteoporosisPhase 2/3NCT02063854
A Phase II/III, Double-blind, Parallel Group Comparative Study of Oral Administration of NE-58095 Tablets
A Phase 2/3 study testing NE-58095 IR and NE-58095 DR in people with Involutional Osteoporosis, run by Takeda at 25 sites in Japan.
Trial summary
The present phase II/III, multicenter, randomized, double-blind, parallel group comparative study is designed to evaluate the efficacy and safety of once-monthly oral administration of NE-58095 delayed release (DR) tablets for 12 months in participants with involutional osteoporosis. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Involutional Osteoporosis
- What is being tested?
- NE-58095 IR and NE-58095 DR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 871 participants
- Where
- 25 sitesJapan
- Study dates
- Feb 2014to Nov 2015
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of involutional osteoporosis
- Male or female outpatients (including patients admitted to the hospital for tests) aged ≥ 50 years at the time of consent
- Women for whom at least 2 years have passed since the last natural menstruation
Who cannot join
- Patients with secondary osteoporosis
- Patients with diseases (other than secondary osteoporosis) that present with decreased bone mass
- Patients with findings that affects the measurement of mean bone mineral density of the lumbar spine by dual-energy X-ray absorptiometry (DXA)
- Patients with a history of radiotherapy to the lumbar spine or the pelvis
- Patients who are planning to receive surgical dental procedures such as tooth extraction (including dental implant treatment) during the treatment period
- Patients with a history of treatment with any anti-receptor activator of nuclear factor-κB ligand (RANKL) monoclonal antibodies or parathyroid hormone products within 1 year before the start of the treatment period
Show all 15Show fewer
- Patients with a history of treatment with any bisphosphonate products within 24 weeks before the start of the treatment period
- Patients who have received any drugs that affect bone metabolism within 8 weeks before the start of the treatment period
- Patients with disorders such as esophagitis, peptic ulcer (e.g., esophageal ulcer, gastric ulcer, and duodenal ulcer), or gastrointestinal bleeding
- Patients with disorders that delay esophageal emptying (e.g., dysphagia, esophagostenosis, or achalasia of the esophagus)
- Patients with hypocalcemia
- Patients with hypercalcemia
- Patients with a diagnosis of renal calculus
- Patients with serious renal, hepatic, or cardiac disease
- Patients who have received surgical dental procedures, such as a tooth extraction (including dental implant treatment), but whose dental problems remain unresolved at the start of the treatment period.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
Japan25 sites
Study site
Atsugi-shi, Kanagawa
Study site
Chiba, Chiba
Study site
Daito-ku, Tokyo
Study site
Ebetsu-shi, Hokkaido
Study site
Fukuoka, Fukuoka
Study site
Higashi Osaka-shi, Osaka
Study site
Kako-gun, Hyōgo
Study site
Kawasaki-shi, Kanagawa
Study site
Kitakyushu-shi, Fukuoka
Study site
Kumamoto, Kumamoto
Study site
Miyazaki, Miyazaki
Study site
Morioka, Iwate
Study site
Nagoya, Aichi-ken
Study site
Narashino-shi, Chiba
Study site
Onga-gun, Fukuoka
Study site
Saitama-shi, Saitama
Study site
Saito-shi, Miyazaki
Study site
Sapporo, Hokkaido
Study site
Sendai, Miyagi
Study site
Setagaya-ku, Tokyo
Study site
Tagajō-shi, Miyagi
Study site
Tamana-shi, Kumamoto
Study site
Wakayama, Wakayama
Study site
Yokohama, Kanagawa
Study site
Zushi-shi, Kanagawa
About this study
Official title: A Phase 2/3, Multicenter, Randomized, Double-blind, Parallel Group Comparative Study to Evaluate the Efficacy and Safety of Once-monthly Oral Administration of NE-58095DR Tablet (25 mg or 37.5 mg) Versus Once-daily Oral Administration of NE-58095IR Tablet (2.5 mg) for the Treatment of Involutional Osteoporosis
The present phase II/III, multicenter, randomized, double-blind, parallel group comparative study is designed to evaluate the efficacy and safety of once-monthly oral administration of NE-58095 delayed release (DR) tablets for 12 months in participants with involutional osteoporosis. For this study, participants receiving oral NE-58095 immediate release (IR) 2.5 mg tablets once daily for 12 months are set as the control group.
Read the detailed description
The primary objective of the present study is to verify the non-inferiority of once-monthly oral administration of NE-58095 DR tablets for 12 months to once-daily oral administration of NE-58095 IR 2.5 mg tablets for 12 months, in terms of efficacy in participants with involutional osteoporosis.
Secondary objectives of the present study are as follows: to compare the safety of once-monthly oral administration of NE-58095 DR tablets for 12 months with the safety of once-daily oral administration of NE-58095 IR tablets (at 2.5 mg) for 12 months in participants with involutional osteoporosis at time of wakening.
- Conditions
- Involutional Osteoporosis
- Being tested
- NE-58095 IR, NE-58095 IR Placebo, NE-58095 DR, NE-58095 DR Placebo
- Keywords
- Drug Therapy
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NE-58095 IRDrug
NE-58095 IR tablets
NE-58095 IR PlaceboDrug
NE-58095 IR placebo-matching tablets
NE-58095 DRDrug
NE-58095 DR tablets
NE-58095 DR PlaceboDrug
NE-58095 DR placebo-matching tablets
| Study group | Role | What they receive |
|---|---|---|
| NE-58095 IR 2.5 mg Once Daily on Awakening | Active comparator | NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication. Receives: Drug: NE-58095 IR; Drug: NE-58095 DR Placebo |
| NE-58095 DR 25 mg Once Monthly on Awakening | Experimental | NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication. Receives: Drug: NE-58095 IR Placebo; Drug: NE-58095 DR; Drug: NE-58095 DR Placebo |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Experimental | NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication. Receives: Drug: NE-58095 IR Placebo; Drug: NE-58095 DR; Drug: NE-58095 DR Placebo |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Experimental | NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication. Receives: Drug: NE-58095 IR Placebo; Drug: NE-58095 DR; Drug: NE-58095 DR Placebo |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Experimental | NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication. Receives: Drug: NE-58095 IR Placebo; Drug: NE-58095 DR; Drug: NE-58095 DR Placebo |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Experimental | NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication. Receives: Drug: NE-58095 IR Placebo; Drug: NE-58095 DR; Drug: NE-58095 DR Placebo |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Experimental | NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication. Receives: Drug: NE-58095 IR Placebo; Drug: NE-58095 DR; Drug: NE-58095 DR Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) Measured by Dual Energy X-Ray Absorptiometry (DXA) at End of Study
The change in BMD in the second to the fourth lumbar vertebrae, L2 to L4, and the averages of L2 to L4 at end of study relative to baseline. DXA is a means of measuring BMD through x-ray.
Measured: Baseline and End of Study (up to Month 12)
Secondary outcomes (10)
Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit
The change in BMD in each vertebra, L2 to L4, and the averages of L2 to L4 at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.
Measured: Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit
The change in BMD in the total proximal femur (whole bone, trochanteric region, and neck region) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.
Measured: Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit
The change in BMD in the femur (trochanter) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.
Measured: Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit
The change in BMD in the femur (femoral neck) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray.
Measured: Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.
Measured: Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.
Measured: Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.
Measured: Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit
Blood samples for serum bone turnover markers were collected at specified visits according to the study schedule. Blood samples were to be collected at about the same time of the day, as far as possible, throughout the study.
Measured: Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit
Urine samples for urine bone turnover markers were collected at specified visits according to the study schedule. Urine samples were to be collected at about the same time of the day, as far as possible, throughout the study. Urine NTX was corrected by creatinine value.
Measured: Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
Percentage of Participants With New Non-traumatic Vertebral Fractures (Including the Worsening of Pre-existing Fractures)
New non-traumatic vertebral fractures were identified by interpretable X-ray images of 13 vertebrae from the fourth thoracic to the fourth lumbar vertebra. A Central Review Committee member for X-ray determined the presence or absence of new vertebral fractures, the number of new fractures, the presence or absence of worsening pre-existing vertebral fractures, and the number of worsened fractures. The assessment of new vertebral fractures and the worsening of pre-existing vertebral fractures was semiquantitative. The X-ray images were visually inspected and classified into normal (Grade 0), mild deformation (Grade 1), moderate deformation (Grade 2), or severe deformation (Grade 3). If the assessment of any vertebra became worse by at least 1 grade after starting the treatment, its height was measured. A new vertebral fracture or a worsening pre-existing vertebral fracture was concluded if the vertebra's height was reduced from the baseline by at least 20% and by at least 4 mm.
Measured: Baseline to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Involutional OsteoporosisStudies of the same condition, open and under way.
- More trials run by TakedaThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 871 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EA Pharma Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063854
- Sponsor's protocol ID
- CCT-401
- Other IDs
- JapicCTI-142440, U1111-1153-0440, NE-58095DR/CCT-401
- Status last verified
- Feb 2017
- First submitted
- 12 Feb 2014
- Last updated
- 23 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3, Multicenter, Randomized, Double-blind, Parallel Group Comparative Study to Evaluate the Efficacy and Safety of Once-monthly Oral Administration of NE-58095DR Tablet (25 mg or 37.5 mg) Versus Once-daily Oral Administration of NE-58095IR Tablet (2.5 mg) for the Treatment of Involutional Osteoporosis
- ClinicalTrials.gov ID
- NCT02063854
- Acronym / sponsor ID
- CCT-401
- Conditions
- Involutional Osteoporosis
- Keywords
- Drug Therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 871 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Collaborators
- EA Pharma Co., Ltd.
- Study start
- Feb 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 14 Feb 2014 (estimated)
- Results
- Posted 23 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present phase II/III, multicenter, randomized, double-blind, parallel group comparative study is designed to evaluate the efficacy and safety of once-monthly oral administration of NE-58095 delayed release (DR) tablets for 12 months in participants with involutional osteoporosis. For this study, participants receiving oral NE-58095 immediate release (IR) 2.5 mg tablets once daily for 12 months are set as the control group.
Detailed description
The primary objective of the present study is to verify the non-inferiority of once-monthly oral administration of NE-58095 DR tablets for 12 months to once-daily oral administration of NE-58095 IR 2.5 mg tablets for 12 months, in terms of efficacy in participants with involutional osteoporosis.
Secondary objectives of the present study are as follows: to compare the safety of once-monthly oral administration of NE-58095 DR tablets for 12 months with the safety of once-daily oral administration of NE-58095 IR tablets (at 2.5 mg) for 12 months in participants with involutional osteoporosis at time of wakening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| NE-58095 IR 2.5 mg Once Daily on Awakening | Active comparator | Drug: NE-58095 IR, Drug: NE-58095 DR PlaceboNE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication. |
| NE-58095 DR 25 mg Once Monthly on Awakening | Experimental | Drug: NE-58095 IR Placebo, Drug: NE-58095 DR, Drug: NE-58095 DR PlaceboNE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication. |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Experimental | Drug: NE-58095 IR Placebo, Drug: NE-58095 DR, Drug: NE-58095 DR PlaceboNE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication. |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Experimental | Drug: NE-58095 IR Placebo, Drug: NE-58095 DR, Drug: NE-58095 DR PlaceboNE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication. |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Experimental | Drug: NE-58095 IR Placebo, Drug: NE-58095 DR, Drug: NE-58095 DR PlaceboNE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication. |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Experimental | Drug: NE-58095 IR Placebo, Drug: NE-58095 DR, Drug: NE-58095 DR PlaceboNE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication. |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Experimental | Drug: NE-58095 IR Placebo, Drug: NE-58095 DR, Drug: NE-58095 DR PlaceboNE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a diagnosis of involutional osteoporosis
- Male or female outpatients (including patients admitted to the hospital for tests) aged ≥ 50 years at the time of consent
- Women for whom at least 2 years have passed since the last natural menstruation
Key exclusion criteria (15 listed)
- Patients with secondary osteoporosis
- Patients with diseases (other than secondary osteoporosis) that present with decreased bone mass
- Patients with findings that affects the measurement of mean bone mineral density of the lumbar spine by dual-energy X-ray absorptiometry (DXA)
- Patients with a history of radiotherapy to the lumbar spine or the pelvis
- Patients who are planning to receive surgical dental procedures such as tooth extraction (including dental implant treatment) during the treatment period
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 |
|---|---|---|
| NE-58095 IRNE-58095 IR tablets | Drug | NE-58095 IR 2.5 mg Once Daily on Awakening |
| NE-58095 IR PlaceboNE-58095 IR placebo-matching tablets | Drug | NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast, NE-58095 DR 25 mg Once Monthly Following Breakfast, NE-58095 DR 25 mg Once Monthly on Awakening, NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast, NE-58095 DR 37.5 mg Once Monthly Following Breakfast, NE-58095 DR 37.5 mg Once Monthly on Awakening |
| NE-58095 DRNE-58095 DR tablets | Drug | NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast, NE-58095 DR 25 mg Once Monthly Following Breakfast, NE-58095 DR 25 mg Once Monthly on Awakening, NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast, NE-58095 DR 37.5 mg Once Monthly Following Breakfast, NE-58095 DR 37.5 mg Once Monthly on Awakening |
| NE-58095 DR PlaceboNE-58095 DR placebo-matching tablets | Drug | NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast, NE-58095 DR 25 mg Once Monthly Following Breakfast, NE-58095 DR 25 mg Once Monthly on Awakening, NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast, NE-58095 DR 37.5 mg Once Monthly Following Breakfast, NE-58095 DR 37.5 mg Once Monthly on Awakening, NE-58095 IR 2.5 mg Once Daily on Awakening |
Primary outcome
Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) Measured by Dual Energy X-Ray Absorptiometry (DXA) at End of Study
Time frame: Baseline and End of Study (up to Month 12)
The change in BMD in the second to the fourth lumbar vertebrae, L2 to L4, and the averages of L2 to L4 at end of study relative to baseline. DXA is a means of measuring BMD through x-ray.
10 secondary outcomes
Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit
Time frame: Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit
Time frame: Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit
Time frame: Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit
Time frame: Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit
Time frame: Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit
Time frame: Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit
Time frame: Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit
Time frame: Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit
Time frame: Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
Percentage of Participants With New Non-traumatic Vertebral Fractures (Including the Worsening of Pre-existing Fractures)
Time frame: Baseline to Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Director Clinical Science study director
Takeda
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing NE-58095 IR and NE-58095 DR in people with Involutional Osteoporosis, run by Takeda at 25 sites in Japan.
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 3 inclusion and 15 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 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Yes. Results are posted in the registry (first posted 23 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change From Baseline in Mean Lumbar Spine (L2-L4) Bone Mineral Density (BMD) Measured by Dual Energy X-Ray Absorptiometry (DXA) at End of Study (time frame: Baseline and End of Study (up to Month 12)). 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 23 Feb 2017.