Involutional Osteoporosis
Conditions
Keywords
Drug Therapy
Brief 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. 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.
Interventions
DRUGNE-58095 IR
NE-58095 IR tablets
DRUGNE-58095 IR Placebo
NE-58095 IR placebo-matching tablets
DRUGNE-58095 DR
NE-58095 DR tablets
DRUGNE-58095 DR Placebo
NE-58095 DR placebo-matching tablets
Sponsors
EA Pharma Co., Ltd.
Takeda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with a diagnosis of involutional osteoporosis 2. Male or female outpatients (including patients admitted to the hospital for tests) aged ≥ 50 years at the time of consent 3. Women for whom at least 2 years have passed since the last natural menstruation
Exclusion criteria
1. Patients with secondary osteoporosis 2. Patients with diseases (other than secondary osteoporosis) that present with decreased bone mass 3. Patients with findings that affects the measurement of mean bone mineral density of the lumbar spine by dual-energy X-ray absorptiometry (DXA) 4. Patients with a history of radiotherapy to the lumbar spine or the pelvis 5. Patients who are planning to receive surgical dental procedures such as tooth extraction (including dental implant treatment) during the treatment period 6. 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 7. Patients with a history of treatment with any bisphosphonate products within 24 weeks before the start of the treatment period 8. Patients who have received any drugs that affect bone metabolism within 8 weeks before the start of the treatment period 9. Patients with disorders such as esophagitis, peptic ulcer (e.g., esophageal ulcer, gastric ulcer, and duodenal ulcer), or gastrointestinal bleeding 10. Patients with disorders that delay esophageal emptying (e.g., dysphagia, esophagostenosis, or achalasia of the esophagus) 11. Patients with hypocalcemia 12. Patients with hypercalcemia 13. Patients with a diagnosis of renal calculus 14. Patients with serious renal, hepatic, or cardiac disease 15. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit | Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12) | 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. |
| Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit | Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12) | The change in BMD in the femur (trochanter) at each visit relative to baseline. DXA is a means of measuring BMD through x-ray. |
| Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit | Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12) | 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. |
| Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12) | 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. |
| Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit | Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12) | 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. |
| Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12) | 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. |
| Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12) | 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. |
| Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12) | 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. |
| Percentage of Participants With New Non-traumatic Vertebral Fractures (Including the Worsening of Pre-existing Fractures) | Baseline to Month 12 | 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. |
| Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12) | 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. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 67 investigative sites in Japan from 21 February 2014 to 19 November 2015.
Pre-assignment details
Participants with a diagnosis of involutional osteoporosis were randomized at a ratio of 3:1:3:1:1:3:1 into 1 of 7 treatment groups: once-daily NE-58095 2.5 mg immediate release (IR) or once-monthly NE-58095 25 mg or 37.5 mg delayed release (DR) on awakening, after breakfast or 30 minutes following breakfast.
Participants by arm
| Arm | Count |
|---|---|
| NE-58095 IR 2.5 mg Once Daily on Awakening 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. | 199 |
| NE-58095 DR 25 mg Once Monthly on Awakening 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. | 66 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast 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. | 206 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast 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. | 68 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening 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. | 65 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast 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. | 201 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast 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. | 66 |
| Total | 871 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Did Not Receive Study Drug | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Major Protocol Deviation | 0 | 0 | 3 | 0 | 0 | 0 | 0 |
| Overall Study | Pretreatment Event/Adverse Event | 13 | 10 | 13 | 8 | 7 | 18 | 4 |
| Overall Study | Reason Not Specified | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Surgical Dental Work Performed/Planned | 5 | 2 | 6 | 1 | 1 | 6 | 1 |
| Overall Study | Voluntary Withdrawal | 2 | 0 | 8 | 1 | 3 | 6 | 1 |
Baseline characteristics
| Characteristic | NE-58095 DR 25 mg Once Monthly on Awakening | NE-58095 IR 2.5 mg Once Daily on Awakening | Total | 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 25 mg Once Monthly 30 Min. After Breakfast | NE-58095 DR 25 mg Once Monthly Following Breakfast |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 69.0 years STANDARD_DEVIATION 8.18 | 68.9 years STANDARD_DEVIATION 7.32 | 68.9 years STANDARD_DEVIATION 7.45 | 69.8 years STANDARD_DEVIATION 7.87 | 69.6 years STANDARD_DEVIATION 7.19 | 69.0 years STANDARD_DEVIATION 6.98 | 68.4 years STANDARD_DEVIATION 7.24 | 68.2 years STANDARD_DEVIATION 7.68 |
| Body Mass Index (BMI) | 21.93 kg/m^2 STANDARD_DEVIATION 2.83 | 21.82 kg/m^2 STANDARD_DEVIATION 3.009 | 21.87 kg/m^2 STANDARD_DEVIATION 3.092 | 21.90 kg/m^2 STANDARD_DEVIATION 3.071 | 22.00 kg/m^2 STANDARD_DEVIATION 3.105 | 21.79 kg/m^2 STANDARD_DEVIATION 3.289 | 21.97 kg/m^2 STANDARD_DEVIATION 3.875 | 21.75 kg/m^2 STANDARD_DEVIATION 2.926 |
| Dual-Energy X-Ray Absorptiometry (DXA) Measuring Apparatus Delphi | 9 participants | 28 participants | 118 participants | 8 participants | 26 participants | 9 participants | 9 participants | 29 participants |
| Dual-Energy X-Ray Absorptiometry (DXA) Measuring Apparatus Discovery | 38 participants | 114 participants | 499 participants | 35 participants | 118 participants | 35 participants | 39 participants | 120 participants |
| Dual-Energy X-Ray Absorptiometry (DXA) Measuring Apparatus Explorer | 14 participants | 43 participants | 192 participants | 17 participants | 45 participants | 15 participants | 15 participants | 43 participants |
| Dual-Energy X-Ray Absorptiometry (DXA) Measuring Apparatus QDR-4500 | 5 participants | 14 participants | 62 participants | 6 participants | 12 participants | 6 participants | 5 participants | 14 participants |
| Femoral Neck BMD | 0.5258 g/cm^2 STANDARD_DEVIATION 0.08147 | 0.5318 g/cm^2 STANDARD_DEVIATION 0.07695 | 0.5327 g/cm^2 STANDARD_DEVIATION 0.07712 | 0.5373 g/cm^2 STANDARD_DEVIATION 0.07346 | 0.5411 g/cm^2 STANDARD_DEVIATION 0.08051 | 0.5245 g/cm^2 STANDARD_DEVIATION 0.06293 | 0.5348 g/cm^2 STANDARD_DEVIATION 0.07154 | 0.5278 g/cm^2 STANDARD_DEVIATION 0.0796 |
| Femoral Neck BMD T-score | -2.9358 score on a scale STANDARD_DEVIATION 0.90523 | -2.8683 score on a scale STANDARD_DEVIATION 0.85505 | -2.8594 score on a scale STANDARD_DEVIATION 0.8569 | -2.8077 score on a scale STANDARD_DEVIATION 0.81618 | -2.7652 score on a scale STANDARD_DEVIATION 0.89454 | -2.9501 score on a scale STANDARD_DEVIATION 0.6992 | -2.8360 score on a scale STANDARD_DEVIATION 0.79487 | -2.9135 score on a scale STANDARD_DEVIATION 0.88448 |
| Fragility Fracture No | 29 participants | 113 participants | 454 participants | 30 participants | 97 participants | 34 participants | 36 participants | 115 participants |
| Fragility Fracture Yes | 37 participants | 86 participants | 417 participants | 36 participants | 104 participants | 31 participants | 32 participants | 91 participants |
| Height | 151.0 cm STANDARD_DEVIATION 6.64 | 152.1 cm STANDARD_DEVIATION 6.59 | 151.9 cm STANDARD_DEVIATION 6 | 151.9 cm STANDARD_DEVIATION 6.47 | 151.3 cm STANDARD_DEVIATION 5.2 | 153.5 cm STANDARD_DEVIATION 5.13 | 152.5 cm STANDARD_DEVIATION 5.49 | 151.9 cm STANDARD_DEVIATION 6.11 |
| History of Bisphosphonate Administration No | 60 participants | 180 participants | 773 participants | 60 participants | 175 participants | 56 participants | 60 participants | 182 participants |
| History of Bisphosphonate Administration Yes | 6 participants | 19 participants | 98 participants | 6 participants | 26 participants | 9 participants | 8 participants | 24 participants |
| L2-L4 (BMD) | 0.6690 g/cm^2 STANDARD_DEVIATION 0.11746 | 0.6553 g/cm^2 STANDARD_DEVIATION 0.0906 | 0.6564 g/cm^2 STANDARD_DEVIATION 0.09303 | 0.6714 g/cm^2 STANDARD_DEVIATION 0.09999 | 0.6589 g/cm^2 STANDARD_DEVIATION 0.09893 | 0.6448 g/cm^2 STANDARD_DEVIATION 0.08909 | 0.6633 g/cm^2 STANDARD_DEVIATION 0.08766 | 0.6477 g/cm^2 STANDARD_DEVIATION 0.08037 |
| L2-L4 BMD T-score | -2.8738 score on a scale STANDARD_DEVIATION 0.98709 | -2.9889 score on a scale STANDARD_DEVIATION 0.7613 | -2.9796 score on a scale STANDARD_DEVIATION 0.78178 | -2.8536 score on a scale STANDARD_DEVIATION 0.8403 | -2.9587 score on a scale STANDARD_DEVIATION 0.83135 | -3.0773 score on a scale STANDARD_DEVIATION 0.74863 | -2.9219 score on a scale STANDARD_DEVIATION 0.7367 | -3.0532 score on a scale STANDARD_DEVIATION 0.67537 |
| L2-L4 BMD T-score, Categorical -0.999 - ≤Max | 3 participants | 2 participants | 17 participants | 3 participants | 4 participants | 0 participants | 2 participants | 3 participants |
| L2-L4 BMD T-score, Categorical -2.499 - ≤-1.000 | 16 participants | 28 participants | 142 participants | 12 participants | 36 participants | 12 participants | 12 participants | 26 participants |
| L2-L4 BMD T-score, Categorical Min - ≤-2.500 | 47 participants | 169 participants | 711 participants | 51 participants | 160 participants | 53 participants | 54 participants | 177 participants |
| Lumbar Spine (L2-L4) Bone Mineral Density (BMD), Categorical 0.708 (70%YAM) - ≤0.808 g/cm^2 | 13 participants | 24 participants | 118 participants | 11 participants | 28 participants | 10 participants | 11 participants | 21 participants |
| Lumbar Spine (L2-L4) Bone Mineral Density (BMD), Categorical 0.809 (80%YAM) g/cm^2 - ≤Max | 7 participants | 8 participants | 50 participants | 6 participants | 14 participants | 3 participants | 3 participants | 9 participants |
| Lumbar Spine (L2-L4) Bone Mineral Density (BMD), Categorical Min - ≤0.707 g/cm^2 | 46 participants | 167 participants | 702 participants | 49 participants | 158 participants | 52 participants | 54 participants | 176 participants |
| Menopausal Status Artificial Menopause | 6 participants | 20 participants | 88 participants | 4 participants | 18 participants | 10 participants | 6 participants | 24 participants |
| Menopausal Status Natural Menopause | 58 participants | 170 participants | 759 participants | 59 participants | 180 participants | 53 participants | 60 participants | 179 participants |
| Number of Existing Vertebral (Thoracic [Th4] -L4) Fractures 0 | 32 participants | 138 participants | 531 participants | 35 participants | 121 participants | 38 participants | 42 participants | 125 participants |
| Number of Existing Vertebral (Thoracic [Th4] -L4) Fractures 1 | 21 participants | 39 participants | 239 participants | 25 participants | 58 participants | 18 participants | 17 participants | 61 participants |
| Number of Existing Vertebral (Thoracic [Th4] -L4) Fractures 2 | 8 participants | 12 participants | 66 participants | 6 participants | 15 participants | 6 participants | 7 participants | 12 participants |
| Number of Existing Vertebral (Thoracic [Th4] -L4) Fractures ≥3 | 5 participants | 10 participants | 34 participants | 0 participants | 6 participants | 3 participants | 2 participants | 8 participants |
| Number of Years After Menopause | 20.2 years STANDARD_DEVIATION 8.72 | 18.6 years STANDARD_DEVIATION 7.81 | 18.7 years STANDARD_DEVIATION 8.28 | 20.1 years STANDARD_DEVIATION 7.84 | 19.5 years STANDARD_DEVIATION 8.41 | 19.2 years STANDARD_DEVIATION 8.36 | 18.3 years STANDARD_DEVIATION 8.28 | 17.2 years STANDARD_DEVIATION 8.44 |
| Number of Years After Menopause, Categorical 11 - ≤20 years | 21 participants | 59 participants | 281 participants | 20 participants | 61 participants | 20 participants | 29 participants | 71 participants |
| Number of Years After Menopause, Categorical 21 - ≤30 years | 19 participants | 55 participants | 224 participants | 19 participants | 58 participants | 19 participants | 12 participants | 42 participants |
| Number of Years After Menopause, Categorical ≥31 years | 6 participants | 9 participants | 58 participants | 4 participants | 17 participants | 4 participants | 7 participants | 11 participants |
| Number of Years After Menopause, Categorical 6 - ≤10 years | 1 participants | 23 participants | 92 participants | 6 participants | 22 participants | 8 participants | 4 participants | 28 participants |
| Number of Years After Menopause, Categorical Min - ≤5 years | 5 participants | 6 participants | 31 participants | 2 participants | 4 participants | 3 participants | 4 participants | 7 participants |
| Number of Years After Menopause, Categorical Unknown, But >2 years | 12 participants | 38 participants | 161 participants | 12 participants | 36 participants | 9 participants | 10 participants | 44 participants |
| Primary Osteoporosis Diagnosis Criteria 2012 Fragility Fracture (Other and BMD<YAM*80%) | 7 participants | 21 participants | 74 participants | 4 participants | 24 participants | 6 participants | 3 participants | 9 participants |
| Primary Osteoporosis Diagnosis Criteria 2012 Fragility Fracture (Vertebrae or Proximal Femur) | 30 participants | 65 participants | 343 participants | 32 participants | 80 participants | 25 participants | 29 participants | 82 participants |
| Primary Osteoporosis Diagnosis Criteria 2012 No Fragility Fracture and BMD<=YAM*70% | 29 participants | 113 participants | 453 participants | 30 participants | 97 participants | 34 participants | 35 participants | 115 participants |
| Region of Enrollment Japan | 66 participants | 199 participants | 871 participants | 66 participants | 201 participants | 65 participants | 68 participants | 206 participants |
| Serum 25-hydroxy Vitamin D (25-OH-D), Categorical 15.0 - ≤27.9 ng/mL | 51 participants | 161 participants | 685 participants | 53 participants | 160 participants | 50 participants | 53 participants | 157 participants |
| Serum 25-hydroxy Vitamin D (25-OH-D), Categorical 28.0 ng/mL - ≤Max | 7 participants | 20 participants | 96 participants | 5 participants | 19 participants | 7 participants | 10 participants | 28 participants |
| Serum 25-hydroxy Vitamin D (25-OH-D), Categorical Min - ≤14.9 ng/mL | 8 participants | 18 participants | 89 participants | 8 participants | 21 participants | 8 participants | 5 participants | 21 participants |
| Serum 25-OH-D | 21.44 ng/mL STANDARD_DEVIATION 5.423 | 21.55 ng/mL STANDARD_DEVIATION 5.266 | 21.42 ng/mL STANDARD_DEVIATION 5.288 | 20.58 ng/mL STANDARD_DEVIATION 4.761 | 21.52 ng/mL STANDARD_DEVIATION 5.121 | 21.17 ng/mL STANDARD_DEVIATION 5.248 | 21.64 ng/mL STANDARD_DEVIATION 5.427 | 21.46 ng/mL STANDARD_DEVIATION 5.592 |
| Serum Bone-type Alkaline Phosphatase (BAP) | 16.88 μg/L STANDARD_DEVIATION 8.617 | 15.91 μg/L STANDARD_DEVIATION 5.809 | 15.79 μg/L STANDARD_DEVIATION 6.142 | 15.13 μg/L STANDARD_DEVIATION 6.815 | 15.13 μg/L STANDARD_DEVIATION 5.164 | 17.17 μg/L STANDARD_DEVIATION 7.354 | 15.45 μg/L STANDARD_DEVIATION 5.024 | 15.83 μg/L STANDARD_DEVIATION 6.035 |
| Serum C-telopeptide of Type 1 Collagen (CTX) | 0.460 ng/mL STANDARD_DEVIATION 0.1855 | 0.444 ng/mL STANDARD_DEVIATION 0.166 | 0.434 ng/mL STANDARD_DEVIATION 0.1696 | 0.399 ng/mL STANDARD_DEVIATION 0.1613 | 0.417 ng/mL STANDARD_DEVIATION 0.1592 | 0.497 ng/mL STANDARD_DEVIATION 0.1867 | 0.421 ng/mL STANDARD_DEVIATION 0.1437 | 0.426 ng/mL STANDARD_DEVIATION 0.1776 |
| Serum Procollagen 1 N-terminal Peptide (P1NP) | 54.91 μg/L STANDARD_DEVIATION 27.552 | 51.79 μg/L STANDARD_DEVIATION 20.357 | 50.44 μg/L STANDARD_DEVIATION 21.648 | 46.04 μg/L STANDARD_DEVIATION 21.714 | 48.53 μg/L STANDARD_DEVIATION 20.366 | 53.43 μg/L STANDARD_DEVIATION 22.783 | 47.83 μg/L STANDARD_DEVIATION 17.12 | 50.89 μg/L STANDARD_DEVIATION 22.635 |
| Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) | 424.1 mU/dL STANDARD_DEVIATION 144.89 | 427.1 mU/dL STANDARD_DEVIATION 154.67 | 418.5 mU/dL STANDARD_DEVIATION 148.29 | 395.0 mU/dL STANDARD_DEVIATION 128.38 | 410.5 mU/dL STANDARD_DEVIATION 142.09 | 444.7 mU/dL STANDARD_DEVIATION 142.9 | 398.4 mU/dL STANDARD_DEVIATION 127.54 | 422.1 mU/dL STANDARD_DEVIATION 162.07 |
| Sex: Female, Male Female | 64 Participants | 190 Participants | 847 Participants | 63 Participants | 198 Participants | 63 Participants | 66 Participants | 203 Participants |
| Sex: Female, Male Male | 2 Participants | 9 Participants | 24 Participants | 3 Participants | 3 Participants | 2 Participants | 2 Participants | 3 Participants |
| Smoking Classification Current smoker | 4 participants | 10 participants | 41 participants | 3 participants | 7 participants | 3 participants | 3 participants | 11 participants |
| Smoking Classification Ex-smoker | 7 participants | 22 participants | 97 participants | 5 participants | 26 participants | 8 participants | 12 participants | 17 participants |
| Smoking Classification Never smoked | 55 participants | 167 participants | 733 participants | 58 participants | 168 participants | 54 participants | 53 participants | 178 participants |
| Timing of Initial Delayed Release (DR) Tablet Administration on Awakening 0.5 to 1.5 Hours before Breakfast | 56 participants | 165 participants | 707 participants | 50 participants | 164 participants | 53 participants | 52 participants | 167 participants |
| Timing of Initial Delayed Release (DR) Tablet Administration on Awakening 1.5 to 2.5 Hours before Breakfast | 8 participants | 29 participants | 135 participants | 15 participants | 27 participants | 8 participants | 13 participants | 35 participants |
| Timing of Initial Delayed Release (DR) Tablet Administration on Awakening 2.5 to 4 Hours before Breakfast | 2 participants | 5 participants | 27 participants | 1 participants | 8 participants | 4 participants | 3 participants | 4 participants |
| Timing of Initial Delayed Release (DR) Tablet Administration on Awakening Less than 30 Minutes before Breakfast | 0 participants | 0 participants | 1 participants | 0 participants | 1 participants | 0 participants | 0 participants | 0 participants |
| Total Proximal Femur BMD | 0.6573 g/cm^2 STANDARD_DEVIATION 0.09537 | 0.6553 g/cm^2 STANDARD_DEVIATION 0.08997 | 0.6548 g/cm^2 STANDARD_DEVIATION 0.08464 | 0.6520 g/cm^2 STANDARD_DEVIATION 0.07289 | 0.6652 g/cm^2 STANDARD_DEVIATION 0.08465 | 0.6486 g/cm^2 STANDARD_DEVIATION 0.06973 | 0.6580 g/cm^2 STANDARD_DEVIATION 0.07982 | 0.6452 g/cm^2 STANDARD_DEVIATION 0.0849 |
| Total Proximal Femur BMD T-score | -2.1770 score on a scale STANDARD_DEVIATION 0.95369 | -2.1972 score on a scale STANDARD_DEVIATION 0.89971 | -2.2021 score on a scale STANDARD_DEVIATION 0.84645 | -2.2305 score on a scale STANDARD_DEVIATION 0.72892 | -2.0978 score on a scale STANDARD_DEVIATION 0.84652 | -2.2642 score on a scale STANDARD_DEVIATION 0.69731 | -2.1699 score on a scale STANDARD_DEVIATION 0.79822 | -2.2982 score on a scale STANDARD_DEVIATION 0.84903 |
| Trochanter BMD | 0.4954 g/cm^2 STANDARD_DEVIATION 0.06803 | 0.4938 g/cm^2 STANDARD_DEVIATION 0.07793 | 0.4925 g/cm^2 STANDARD_DEVIATION 0.06914 | 0.4900 g/cm^2 STANDARD_DEVIATION 0.06824 | 0.5009 g/cm^2 STANDARD_DEVIATION 0.06626 | 0.4879 g/cm^2 STANDARD_DEVIATION 0.05653 | 0.4932 g/cm^2 STANDARD_DEVIATION 0.07164 | 0.4844 g/cm^2 STANDARD_DEVIATION 0.0661 |
| Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) | 61.04 nmol BCE/mmol-CRE STANDARD_DEVIATION 34.808 | 56.76 nmol BCE/mmol-CRE STANDARD_DEVIATION 26.169 | 56.24 nmol BCE/mmol-CRE STANDARD_DEVIATION 25.871 | 53.66 nmol BCE/mmol-CRE STANDARD_DEVIATION 23.911 | 54.48 nmol BCE/mmol-CRE STANDARD_DEVIATION 23.988 | 64.44 nmol BCE/mmol-CRE STANDARD_DEVIATION 29.535 | 53.77 nmol BCE/mmol-CRE STANDARD_DEVIATION 22.739 | 54.98 nmol BCE/mmol-CRE STANDARD_DEVIATION 23.928 |
| Weight | 49.98 kg STANDARD_DEVIATION 6.72 | 50.52 kg STANDARD_DEVIATION 7.975 | 50.46 kg STANDARD_DEVIATION 7.544 | 50.51 kg STANDARD_DEVIATION 7.427 | 50.36 kg STANDARD_DEVIATION 7.383 | 51.26 kg STANDARD_DEVIATION 7.473 | 50.97 kg STANDARD_DEVIATION 8.736 | 50.20 kg STANDARD_DEVIATION 7.231 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 128 / 199 | 43 / 66 | 132 / 206 | 43 / 68 | 46 / 65 | 138 / 200 | 42 / 66 |
| serious Total, serious adverse events | 12 / 199 | 5 / 66 | 11 / 206 | 7 / 68 | 2 / 65 | 8 / 200 | 3 / 66 |
Outcome results
Primary
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.
Time frame: Baseline and End of Study (up to Month 12)
Population: Full Analysis Set (FAS), all randomized participants who received at least 1 dose of study drug, with data available for analyses.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| NE-58095 IR 2.5 mg Once Daily on Awakening | 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 | 5.07 percent change | Standard Deviation 4.749 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | 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 | 3.36 percent change | Standard Deviation 4.332 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | 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 | 4.11 percent change | Standard Deviation 4.654 |
p-value: 0.1346t-test, 1 sided
p-value: 0.6711t-test, 1 sided
95% CI: [-1.92, 0.001]
95% CI: [-2.617, -0.794]
95% CI: [-0.166, 1.658]
Secondary
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.
Time frame: Baseline to Month 12
Population: FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percentage of Participants With New Non-traumatic Vertebral Fractures (Including the Worsening of Pre-existing Fractures) | Yes | 2.1 percentage of participants |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percentage of Participants With New Non-traumatic Vertebral Fractures (Including the Worsening of Pre-existing Fractures) | No | 97.9 percentage of participants |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percentage of Participants With New Non-traumatic Vertebral Fractures (Including the Worsening of Pre-existing Fractures) | Yes | 3.3 percentage of participants |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percentage of Participants With New Non-traumatic Vertebral Fractures (Including the Worsening of Pre-existing Fractures) | No | 96.7 percentage of participants |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percentage of Participants With New Non-traumatic Vertebral Fractures (Including the Worsening of Pre-existing Fractures) | Yes | 2.1 percentage of participants |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percentage of Participants With New Non-traumatic Vertebral Fractures (Including the Worsening of Pre-existing Fractures) | No | 97.9 percentage of participants |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percentage of Participants With New Non-traumatic Vertebral Fractures (Including the Worsening of Pre-existing Fractures) | Yes | 3.2 percentage of participants |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percentage of Participants With New Non-traumatic Vertebral Fractures (Including the Worsening of Pre-existing Fractures) | No | 96.8 percentage of participants |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percentage of Participants With New Non-traumatic Vertebral Fractures (Including the Worsening of Pre-existing Fractures) | Yes | 3.4 percentage of participants |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percentage of Participants With New Non-traumatic Vertebral Fractures (Including the Worsening of Pre-existing Fractures) | No | 96.6 percentage of participants |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percentage of Participants With New Non-traumatic Vertebral Fractures (Including the Worsening of Pre-existing Fractures) | Yes | 1.1 percentage of participants |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percentage of Participants With New Non-traumatic Vertebral Fractures (Including the Worsening of Pre-existing Fractures) | No | 98.9 percentage of participants |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percentage of Participants With New Non-traumatic Vertebral Fractures (Including the Worsening of Pre-existing Fractures) | Yes | 1.6 percentage of participants |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percentage of Participants With New Non-traumatic Vertebral Fractures (Including the Worsening of Pre-existing Fractures) | No | 98.4 percentage of participants |
Secondary
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.
Time frame: Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
Population: FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 1 (n=199, 66, 205, 68, 65, 200, 66) | -3.04 percent change | Standard Deviation 11.881 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 6 (n=188, 61, 190, 60, 58, 178, 63) | -28.66 percent change | Standard Deviation 19.087 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 12 (n=181, 55, 178, 59, 54, 170, 60) | -34.53 percent change | Standard Deviation 20.506 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | End of Study (n=199, 66, 205, 68, 65, 200, 66) | -33.34 percent change | Standard Deviation 21.428 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 3 (n=193, 63, 193, 65, 60, 184, 63) | -21.56 percent change | Standard Deviation 15.047 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 9 (n=185, 61, 185, 59, 55, 175, 61) | -32.84 percent change | Standard Deviation 17.7 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 9 (n=185, 61, 185, 59, 55, 175, 61) | -25.23 percent change | Standard Deviation 24.949 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 12 (n=181, 55, 178, 59, 54, 170, 60) | -29.23 percent change | Standard Deviation 22.721 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 1 (n=199, 66, 205, 68, 65, 200, 66) | -2.93 percent change | Standard Deviation 13.365 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 6 (n=188, 61, 190, 60, 58, 178, 63) | -20.92 percent change | Standard Deviation 23.433 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | End of Study (n=199, 66, 205, 68, 65, 200, 66) | -26.27 percent change | Standard Deviation 24.287 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 3 (n=193, 63, 193, 65, 60, 184, 63) | -13.64 percent change | Standard Deviation 18.499 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 1 (n=199, 66, 205, 68, 65, 200, 66) | -2.61 percent change | Standard Deviation 11.351 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 9 (n=185, 61, 185, 59, 55, 175, 61) | -22.48 percent change | Standard Deviation 22.233 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | End of Study (n=199, 66, 205, 68, 65, 200, 66) | -23.11 percent change | Standard Deviation 21.553 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 3 (n=193, 63, 193, 65, 60, 184, 63) | -13.31 percent change | Standard Deviation 17.846 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 12 (n=181, 55, 178, 59, 54, 170, 60) | -24.91 percent change | Standard Deviation 21.537 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 6 (n=188, 61, 190, 60, 58, 178, 63) | -17.93 percent change | Standard Deviation 21.202 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 12 (n=181, 55, 178, 59, 54, 170, 60) | -30.51 percent change | Standard Deviation 17.29 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 1 (n=199, 66, 205, 68, 65, 200, 66) | -3.61 percent change | Standard Deviation 12.135 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 3 (n=193, 63, 193, 65, 60, 184, 63) | -15.99 percent change | Standard Deviation 19.091 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 6 (n=188, 61, 190, 60, 58, 178, 63) | -23.90 percent change | Standard Deviation 18.99 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 9 (n=185, 61, 185, 59, 55, 175, 61) | -28.00 percent change | Standard Deviation 20.334 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | End of Study (n=199, 66, 205, 68, 65, 200, 66) | -27.21 percent change | Standard Deviation 19.932 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 9 (n=185, 61, 185, 59, 55, 175, 61) | -33.15 percent change | Standard Deviation 16.226 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 3 (n=193, 63, 193, 65, 60, 184, 63) | -24.85 percent change | Standard Deviation 14.835 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 12 (n=181, 55, 178, 59, 54, 170, 60) | -38.06 percent change | Standard Deviation 15.153 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | End of Study (n=199, 66, 205, 68, 65, 200, 66) | -33.94 percent change | Standard Deviation 18.14 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 6 (n=188, 61, 190, 60, 58, 178, 63) | -31.06 percent change | Standard Deviation 14.859 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 1 (n=199, 66, 205, 68, 65, 200, 66) | -4.16 percent change | Standard Deviation 13.493 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 6 (n=188, 61, 190, 60, 58, 178, 63) | -24.06 percent change | Standard Deviation 19.744 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 9 (n=185, 61, 185, 59, 55, 175, 61) | -28.70 percent change | Standard Deviation 19.536 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 3 (n=193, 63, 193, 65, 60, 184, 63) | -17.52 percent change | Standard Deviation 18.589 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 12 (n=181, 55, 178, 59, 54, 170, 60) | -29.58 percent change | Standard Deviation 21.56 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 1 (n=199, 66, 205, 68, 65, 200, 66) | -3.69 percent change | Standard Deviation 13.142 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | End of Study (n=199, 66, 205, 68, 65, 200, 66) | -27.52 percent change | Standard Deviation 21.962 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 6 (n=188, 61, 190, 60, 58, 178, 63) | -23.80 percent change | Standard Deviation 18.352 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 3 (n=193, 63, 193, 65, 60, 184, 63) | -13.83 percent change | Standard Deviation 24.858 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | End of Study (n=199, 66, 205, 68, 65, 200, 66) | -27.08 percent change | Standard Deviation 21.632 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 9 (n=185, 61, 185, 59, 55, 175, 61) | -25.84 percent change | Standard Deviation 21.043 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 12 (n=181, 55, 178, 59, 54, 170, 60) | -27.74 percent change | Standard Deviation 21.032 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Bone-type Alkaline Phosphatase (BAP) at Each Visit | Month 1 (n=199, 66, 205, 68, 65, 200, 66) | -2.44 percent change | Standard Deviation 10.662 |
Secondary
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.
Time frame: Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
Population: FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | End of Study (n=199, 66, 204, 68, 65, 200, 66) | -47.61 percent change | Standard Deviation 28.275 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 3 (n=193, 63, 193, 65, 60, 184, 63) | -47.79 percent change | Standard Deviation 25.044 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 9 (n=185, 60, 185, 59, 55, 175, 61) | -52.44 percent change | Standard Deviation 26.256 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 1 (n=199, 66, 204, 68, 65, 200, 66) | -41.02 percent change | Standard Deviation 27.396 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 6 (n=188, 61, 190, 60, 58, 178, 63) | -52.42 percent change | Standard Deviation 22.926 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 12 (n=181, 55, 178, 59, 54, 170, 60) | -48.98 percent change | Standard Deviation 28.051 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 1 (n=199, 66, 204, 68, 65, 200, 66) | -17.42 percent change | Standard Deviation 27.978 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 9 (n=185, 60, 185, 59, 55, 175, 61) | -33.61 percent change | Standard Deviation 27.438 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | End of Study (n=199, 66, 204, 68, 65, 200, 66) | -29.94 percent change | Standard Deviation 36.896 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 3 (n=193, 63, 193, 65, 60, 184, 63) | -29.29 percent change | Standard Deviation 22.794 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 12 (n=181, 55, 178, 59, 54, 170, 60) | -32.11 percent change | Standard Deviation 32.662 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 6 (n=188, 61, 190, 60, 58, 178, 63) | -36.97 percent change | Standard Deviation 29.126 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 12 (n=181, 55, 178, 59, 54, 170, 60) | -16.42 percent change | Standard Deviation 64.139 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 6 (n=188, 61, 190, 60, 58, 178, 63) | -24.39 percent change | Standard Deviation 38.994 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | End of Study (n=199, 66, 204, 68, 65, 200, 66) | -16.27 percent change | Standard Deviation 60.895 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 9 (n=185, 60, 185, 59, 55, 175, 61) | -16.75 percent change | Standard Deviation 83.047 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 1 (n=199, 66, 204, 68, 65, 200, 66) | -15.53 percent change | Standard Deviation 26.107 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 3 (n=193, 63, 193, 65, 60, 184, 63) | -24.80 percent change | Standard Deviation 31.118 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 12 (n=181, 55, 178, 59, 54, 170, 60) | -23.68 percent change | Standard Deviation 44.492 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 1 (n=199, 66, 204, 68, 65, 200, 66) | -18.80 percent change | Standard Deviation 25.956 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 3 (n=193, 63, 193, 65, 60, 184, 63) | -28.76 percent change | Standard Deviation 28.409 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 6 (n=188, 61, 190, 60, 58, 178, 63) | -35.33 percent change | Standard Deviation 24.539 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 9 (n=185, 60, 185, 59, 55, 175, 61) | -27.99 percent change | Standard Deviation 32.106 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | End of Study (n=199, 66, 204, 68, 65, 200, 66) | -24.33 percent change | Standard Deviation 43.256 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 9 (n=185, 60, 185, 59, 55, 175, 61) | -42.94 percent change | Standard Deviation 24.912 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 3 (n=193, 63, 193, 65, 60, 184, 63) | -36.36 percent change | Standard Deviation 23.925 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 12 (n=181, 55, 178, 59, 54, 170, 60) | -40.00 percent change | Standard Deviation 26.613 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | End of Study (n=199, 66, 204, 68, 65, 200, 66) | -39.58 percent change | Standard Deviation 26.203 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 6 (n=188, 61, 190, 60, 58, 178, 63) | -44.28 percent change | Standard Deviation 24.39 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 1 (n=199, 66, 204, 68, 65, 200, 66) | -33.52 percent change | Standard Deviation 24.667 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 6 (n=188, 61, 190, 60, 58, 178, 63) | -37.65 percent change | Standard Deviation 28.327 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 9 (n=185, 60, 185, 59, 55, 175, 61) | -34.50 percent change | Standard Deviation 33.805 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 3 (n=193, 63, 193, 65, 60, 184, 63) | -31.30 percent change | Standard Deviation 28.196 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 12 (n=181, 55, 178, 59, 54, 170, 60) | -31.56 percent change | Standard Deviation 36.239 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 1 (n=199, 66, 204, 68, 65, 200, 66) | -24.74 percent change | Standard Deviation 28.675 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | End of Study (n=199, 66, 204, 68, 65, 200, 66) | -32.33 percent change | Standard Deviation 35.959 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 6 (n=188, 61, 190, 60, 58, 178, 63) | -35.13 percent change | Standard Deviation 25.91 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 3 (n=193, 63, 193, 65, 60, 184, 63) | -29.94 percent change | Standard Deviation 26.889 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | End of Study (n=199, 66, 204, 68, 65, 200, 66) | -26.28 percent change | Standard Deviation 36.284 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 9 (n=185, 60, 185, 59, 55, 175, 61) | -30.97 percent change | Standard Deviation 32.819 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 12 (n=181, 55, 178, 59, 54, 170, 60) | -24.62 percent change | Standard Deviation 37.156 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Creatinine (CTX) at Each Visit | Month 1 (n=199, 66, 204, 68, 65, 200, 66) | -19.34 percent change | Standard Deviation 28.442 |
Secondary
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.
Time frame: Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
Population: FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | End of Study (n=198, 66, 206, 68, 64, 200, 66) | -41.93 percent change | Standard Deviation 31.952 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 3 (n=192, 63, 194, 64, 59, 184, 63) | -45.59 percent change | Standard Deviation 19.379 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 9 (n=184, 61, 186, 59, 54, 175, 61) | -46.82 percent change | Standard Deviation 29.82 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 1 (n=196, 66, 206, 68, 64, 200, 66) | -6.55 percent change | Standard Deviation 17.134 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 6 (n=187, 61, 191, 60, 57, 178, 63) | -50.83 percent change | Standard Deviation 22.45 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 12 (n=180, 55, 179, 59, 53, 170, 60) | -42.90 percent change | Standard Deviation 31.614 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 1 (n=196, 66, 206, 68, 64, 200, 66) | -9.08 percent change | Standard Deviation 16.765 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 9 (n=184, 61, 186, 59, 54, 175, 61) | -34.80 percent change | Standard Deviation 29.523 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | End of Study (n=198, 66, 206, 68, 64, 200, 66) | -32.03 percent change | Standard Deviation 31.584 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 3 (n=192, 63, 194, 64, 59, 184, 63) | -32.19 percent change | Standard Deviation 27.464 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 12 (n=180, 55, 179, 59, 53, 170, 60) | -35.65 percent change | Standard Deviation 27.158 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 6 (n=187, 61, 191, 60, 57, 178, 63) | -39.51 percent change | Standard Deviation 27.766 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 12 (n=180, 55, 179, 59, 53, 170, 60) | -25.32 percent change | Standard Deviation 36.833 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 6 (n=187, 61, 191, 60, 57, 178, 63) | -33.02 percent change | Standard Deviation 35.354 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | End of Study (n=198, 66, 206, 68, 64, 200, 66) | -25.51 percent change | Standard Deviation 35.324 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 9 (n=184, 61, 186, 59, 54, 175, 61) | -27.74 percent change | Standard Deviation 38.273 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 1 (n=196, 66, 206, 68, 64, 200, 66) | -7.70 percent change | Standard Deviation 15.206 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 3 (n=192, 63, 194, 64, 59, 184, 63) | -29.09 percent change | Standard Deviation 26.955 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 12 (n=180, 55, 179, 59, 53, 170, 60) | -31.80 percent change | Standard Deviation 28.472 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 1 (n=196, 66, 206, 68, 64, 200, 66) | -9.73 percent change | Standard Deviation 16.472 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 3 (n=192, 63, 194, 64, 59, 184, 63) | -34.30 percent change | Standard Deviation 20.73 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 6 (n=187, 61, 191, 60, 57, 178, 63) | -39.21 percent change | Standard Deviation 23.522 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 9 (n=184, 61, 186, 59, 54, 175, 61) | -36.41 percent change | Standard Deviation 24.862 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | End of Study (n=198, 66, 206, 68, 64, 200, 66) | -30.67 percent change | Standard Deviation 27.441 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 9 (n=184, 61, 186, 59, 54, 175, 61) | -46.14 percent change | Standard Deviation 21.531 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 3 (n=192, 63, 194, 64, 59, 184, 63) | -45.91 percent change | Standard Deviation 22.176 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 12 (n=180, 55, 179, 59, 53, 170, 60) | -42.75 percent change | Standard Deviation 24.603 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | End of Study (n=198, 66, 206, 68, 64, 200, 66) | -40.82 percent change | Standard Deviation 24.646 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 6 (n=187, 61, 191, 60, 57, 178, 63) | -51.40 percent change | Standard Deviation 18.641 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 1 (n=196, 66, 206, 68, 64, 200, 66) | -13.68 percent change | Standard Deviation 16.892 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 6 (n=187, 61, 191, 60, 57, 178, 63) | -42.21 percent change | Standard Deviation 26.918 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 9 (n=184, 61, 186, 59, 54, 175, 61) | -38.32 percent change | Standard Deviation 30.139 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 3 (n=192, 63, 194, 64, 59, 184, 63) | -36.80 percent change | Standard Deviation 29.014 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 12 (n=180, 55, 179, 59, 53, 170, 60) | -31.33 percent change | Standard Deviation 33.403 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 1 (n=196, 66, 206, 68, 64, 200, 66) | -9.86 percent change | Standard Deviation 14.908 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | End of Study (n=198, 66, 206, 68, 64, 200, 66) | -31.74 percent change | Standard Deviation 31.892 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 6 (n=187, 61, 191, 60, 57, 178, 63) | -40.90 percent change | Standard Deviation 26.225 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 3 (n=192, 63, 194, 64, 59, 184, 63) | -34.14 percent change | Standard Deviation 24.153 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | End of Study (n=198, 66, 206, 68, 64, 200, 66) | -29.13 percent change | Standard Deviation 34.616 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 9 (n=184, 61, 186, 59, 54, 175, 61) | -32.09 percent change | Standard Deviation 36.574 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 12 (n=180, 55, 179, 59, 53, 170, 60) | -29.11 percent change | Standard Deviation 35.904 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Procollagen 1 N-terminal Peptide (P1NP) at Each Visit | Month 1 (n=196, 66, 206, 68, 64, 200, 66) | -10.07 percent change | Standard Deviation 15.969 |
Secondary
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.
Time frame: Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
Population: FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | End of Study (n=199, 66, 205, 68, 65, 200, 66) | -34.76 percent change | Standard Deviation 20.602 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 3 (n=193, 63, 193, 65, 60, 184, 63) | -37.27 percent change | Standard Deviation 17.105 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 9 (n=185, 61, 185, 59, 55, 175, 61) | -37.64 percent change | Standard Deviation 19.734 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 1 (n=199, 66, 205, 68, 65, 200, 66) | -32.38 percent change | Standard Deviation 17.664 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 6 (n=188, 61, 190, 60, 58, 178, 63) | -39.48 percent change | Standard Deviation 17.702 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 12 (n=181, 55, 178, 59, 54, 170, 60) | -34.91 percent change | Standard Deviation 20.628 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 1 (n=199, 66, 205, 68, 65, 200, 66) | -17.26 percent change | Standard Deviation 20.728 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 9 (n=185, 61, 185, 59, 55, 175, 61) | -25.82 percent change | Standard Deviation 24.762 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | End of Study (n=199, 66, 205, 68, 65, 200, 66) | -22.93 percent change | Standard Deviation 26.532 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 3 (n=193, 63, 193, 65, 60, 184, 63) | -25.46 percent change | Standard Deviation 18.567 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 12 (n=181, 55, 178, 59, 54, 170, 60) | -23.70 percent change | Standard Deviation 25.425 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 6 (n=188, 61, 190, 60, 58, 178, 63) | -29.15 percent change | Standard Deviation 21.223 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 12 (n=181, 55, 178, 59, 54, 170, 60) | -13.25 percent change | Standard Deviation 63.783 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 6 (n=188, 61, 190, 60, 58, 178, 63) | -23.87 percent change | Standard Deviation 27.077 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | End of Study (n=199, 66, 205, 68, 65, 200, 66) | -13.86 percent change | Standard Deviation 60.015 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 9 (n=185, 61, 185, 59, 55, 175, 61) | -19.44 percent change | Standard Deviation 45.595 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 1 (n=199, 66, 205, 68, 65, 200, 66) | -17.49 percent change | Standard Deviation 19.406 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 3 (n=193, 63, 193, 65, 60, 184, 63) | -23.85 percent change | Standard Deviation 22.714 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 12 (n=181, 55, 178, 59, 54, 170, 60) | -20.54 percent change | Standard Deviation 26.613 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 1 (n=199, 66, 205, 68, 65, 200, 66) | -21.05 percent change | Standard Deviation 17.749 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 3 (n=193, 63, 193, 65, 60, 184, 63) | -27.46 percent change | Standard Deviation 19.454 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 6 (n=188, 61, 190, 60, 58, 178, 63) | -29.38 percent change | Standard Deviation 20.34 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 9 (n=185, 61, 185, 59, 55, 175, 61) | -24.78 percent change | Standard Deviation 22.657 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | End of Study (n=199, 66, 205, 68, 65, 200, 66) | -21.29 percent change | Standard Deviation 26.141 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 9 (n=185, 61, 185, 59, 55, 175, 61) | -32.78 percent change | Standard Deviation 21.561 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 3 (n=193, 63, 193, 65, 60, 184, 63) | -33.70 percent change | Standard Deviation 20.735 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 12 (n=181, 55, 178, 59, 54, 170, 60) | -31.03 percent change | Standard Deviation 22.287 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | End of Study (n=199, 66, 205, 68, 65, 200, 66) | -31.97 percent change | Standard Deviation 21.945 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 6 (n=188, 61, 190, 60, 58, 178, 63) | -37.16 percent change | Standard Deviation 18.794 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 1 (n=199, 66, 205, 68, 65, 200, 66) | -30.75 percent change | Standard Deviation 19.626 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 6 (n=188, 61, 190, 60, 58, 178, 63) | -31.49 percent change | Standard Deviation 21.748 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 9 (n=185, 61, 185, 59, 55, 175, 61) | -28.83 percent change | Standard Deviation 24.971 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 3 (n=193, 63, 193, 65, 60, 184, 63) | -28.36 percent change | Standard Deviation 20.299 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 12 (n=181, 55, 178, 59, 54, 170, 60) | -24.31 percent change | Standard Deviation 26.832 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 1 (n=199, 66, 205, 68, 65, 200, 66) | -25.20 percent change | Standard Deviation 19.726 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | End of Study (n=199, 66, 205, 68, 65, 200, 66) | -25.93 percent change | Standard Deviation 26.283 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 6 (n=188, 61, 190, 60, 58, 178, 63) | -30.67 percent change | Standard Deviation 21.385 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 3 (n=193, 63, 193, 65, 60, 184, 63) | -27.13 percent change | Standard Deviation 22.146 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | End of Study (n=199, 66, 205, 68, 65, 200, 66) | -24.46 percent change | Standard Deviation 25.027 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 9 (n=185, 61, 185, 59, 55, 175, 61) | -29.71 percent change | Standard Deviation 23.2 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 12 (n=181, 55, 178, 59, 54, 170, 60) | -23.21 percent change | Standard Deviation 25.372 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Serum Tartrate-resistant Acid Phosphatase 5b (TRACP-5b) at Each Visit | Month 1 (n=199, 66, 205, 68, 65, 200, 66) | -22.06 percent change | Standard Deviation 20.097 |
Secondary
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.
Time frame: Baseline and Months 1, 3, 6, 9 and 12 and End of Study (Last observation carried forward at Month 12)
Population: FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 9 (n=185, 61, 186, 59, 55, 175, 61) | -30.97 percent change | Standard Deviation 38.541 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | End of Study (n=199, 66, 206, 68, 65, 200, 66) | -35.30 percent change | Standard Deviation 37.274 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 1 (n=199, 66, 206, 68, 65, 200, 66) | -32.73 percent change | Standard Deviation 29.296 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 3 (n=193, 63, 194, 65, 60, 184, 63) | -37.94 percent change | Standard Deviation 30.36 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 6 (n=188, 61, 191, 60, 58, 178, 63) | -35.00 percent change | Standard Deviation 35.405 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 12 (n=181, 55, 179, 59, 54, 170, 60) | -35.64 percent change | Standard Deviation 37.715 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 6 (n=188, 61, 191, 60, 58, 178, 63) | -29.69 percent change | Standard Deviation 37.178 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 1 (n=199, 66, 206, 68, 65, 200, 66) | -11.79 percent change | Standard Deviation 38.228 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 9 (n=185, 61, 186, 59, 55, 175, 61) | -17.23 percent change | Standard Deviation 38.383 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | End of Study (n=199, 66, 206, 68, 65, 200, 66) | -25.83 percent change | Standard Deviation 32.786 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 3 (n=193, 63, 194, 65, 60, 184, 63) | -22.32 percent change | Standard Deviation 35.861 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 12 (n=181, 55, 179, 59, 54, 170, 60) | -27.45 percent change | Standard Deviation 33.172 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 12 (n=181, 55, 179, 59, 54, 170, 60) | -4.66 percent change | Standard Deviation 61.863 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 6 (n=188, 61, 191, 60, 58, 178, 63) | -7.96 percent change | Standard Deviation 52.202 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | End of Study (n=199, 66, 206, 68, 65, 200, 66) | -4.72 percent change | Standard Deviation 59.237 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 9 (n=185, 61, 186, 59, 55, 175, 61) | -7.71 percent change | Standard Deviation 50.697 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 1 (n=199, 66, 206, 68, 65, 200, 66) | -12.42 percent change | Standard Deviation 35.178 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 3 (n=193, 63, 194, 65, 60, 184, 63) | -15.64 percent change | Standard Deviation 39.676 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 9 (n=185, 61, 186, 59, 55, 175, 61) | -19.48 percent change | Standard Deviation 36.149 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 1 (n=199, 66, 206, 68, 65, 200, 66) | -17.15 percent change | Standard Deviation 40.458 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 3 (n=193, 63, 194, 65, 60, 184, 63) | -20.24 percent change | Standard Deviation 37.412 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 6 (n=188, 61, 191, 60, 58, 178, 63) | -19.51 percent change | Standard Deviation 41.804 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 12 (n=181, 55, 179, 59, 54, 170, 60) | -24.87 percent change | Standard Deviation 34.422 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | End of Study (n=199, 66, 206, 68, 65, 200, 66) | -23.18 percent change | Standard Deviation 35.863 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 9 (n=185, 61, 186, 59, 55, 175, 61) | -31.25 percent change | Standard Deviation 26.172 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 3 (n=193, 63, 194, 65, 60, 184, 63) | -31.27 percent change | Standard Deviation 28.984 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 12 (n=181, 55, 179, 59, 54, 170, 60) | -31.74 percent change | Standard Deviation 34.664 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 6 (n=188, 61, 191, 60, 58, 178, 63) | -36.99 percent change | Standard Deviation 28.317 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 1 (n=199, 66, 206, 68, 65, 200, 66) | -29.81 percent change | Standard Deviation 29.087 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | End of Study (n=199, 66, 206, 68, 65, 200, 66) | -31.55 percent change | Standard Deviation 35.083 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 6 (n=188, 61, 191, 60, 58, 178, 63) | -20.79 percent change | Standard Deviation 40.913 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | End of Study (n=199, 66, 206, 68, 65, 200, 66) | -21.06 percent change | Standard Deviation 53.671 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 9 (n=185, 61, 186, 59, 55, 175, 61) | -15.90 percent change | Standard Deviation 47.103 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 3 (n=193, 63, 194, 65, 60, 184, 63) | -22.60 percent change | Standard Deviation 35.284 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 12 (n=181, 55, 179, 59, 54, 170, 60) | -17.68 percent change | Standard Deviation 55.937 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 1 (n=199, 66, 206, 68, 65, 200, 66) | -16.42 percent change | Standard Deviation 39.131 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 12 (n=181, 55, 179, 59, 54, 170, 60) | -21.94 percent change | Standard Deviation 42.649 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 1 (n=199, 66, 206, 68, 65, 200, 66) | -12.64 percent change | Standard Deviation 42.198 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | End of Study (n=199, 66, 206, 68, 65, 200, 66) | -24.14 percent change | Standard Deviation 42.102 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 9 (n=185, 61, 186, 59, 55, 175, 61) | -14.07 percent change | Standard Deviation 46.266 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 6 (n=188, 61, 191, 60, 58, 178, 63) | -20.92 percent change | Standard Deviation 38.419 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Bone Turnover Marker Urine Type 1 Collagen Cross-linked N-telopeptide (NTX) at Each Visit | Month 3 (n=193, 63, 194, 65, 60, 184, 63) | -20.70 percent change | Standard Deviation 37.137 |
Secondary
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.
Time frame: Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
Population: FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit | End of Study (n=189, 62, 194, 61, 59, 180, 63) | 1.96 percent change | Standard Deviation 4.017 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit | Month 12 (n=181, 58, 180, 59, 55, 172, 61) | 2.00 percent change | Standard Deviation 4.01 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit | Month 6 (n=189, 62, 194, 61, 59, 180, 63) | 1.07 percent change | Standard Deviation 3.406 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit | Month 12 (n=181, 58, 180, 59, 55, 172, 61) | 0.78 percent change | Standard Deviation 4.302 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit | Month 6 (n=189, 62, 194, 61, 59, 180, 63) | 0.90 percent change | Standard Deviation 3.903 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit | End of Study (n=189, 62, 194, 61, 59, 180, 63) | 0.99 percent change | Standard Deviation 4.451 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit | End of Study (n=189, 62, 194, 61, 59, 180, 63) | 1.30 percent change | Standard Deviation 4.638 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit | Month 6 (n=189, 62, 194, 61, 59, 180, 63) | 0.71 percent change | Standard Deviation 4.205 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit | Month 12 (n=181, 58, 180, 59, 55, 172, 61) | 1.34 percent change | Standard Deviation 4.687 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit | Month 12 (n=181, 58, 180, 59, 55, 172, 61) | 1.47 percent change | Standard Deviation 4.055 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit | Month 6 (n=189, 62, 194, 61, 59, 180, 63) | 0.49 percent change | Standard Deviation 3.804 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit | End of Study (n=189, 62, 194, 61, 59, 180, 63) | 1.55 percent change | Standard Deviation 4.009 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit | Month 12 (n=181, 58, 180, 59, 55, 172, 61) | 1.00 percent change | Standard Deviation 3.799 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit | Month 6 (n=189, 62, 194, 61, 59, 180, 63) | 1.01 percent change | Standard Deviation 3.732 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit | End of Study (n=189, 62, 194, 61, 59, 180, 63) | 0.96 percent change | Standard Deviation 3.754 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit | Month 6 (n=189, 62, 194, 61, 59, 180, 63) | 0.57 percent change | Standard Deviation 3.572 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit | End of Study (n=189, 62, 194, 61, 59, 180, 63) | 1.29 percent change | Standard Deviation 3.578 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit | Month 12 (n=181, 58, 180, 59, 55, 172, 61) | 1.24 percent change | Standard Deviation 3.492 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit | End of Study (n=189, 62, 194, 61, 59, 180, 63) | 0.52 percent change | Standard Deviation 3.962 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit | Month 12 (n=181, 58, 180, 59, 55, 172, 61) | 0.56 percent change | Standard Deviation 4.02 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Femur (Femoral Neck) BMD Measured by DXA at Each Visit | Month 6 (n=189, 62, 194, 61, 59, 180, 63) | 0.67 percent change | Standard Deviation 2.77 |
Secondary
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.
Time frame: Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
Population: FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit | End of Study (n=189, 62, 194, 61, 59, 180, 63) | 1.96 percent change | Standard Deviation 3.288 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit | Month 12 (n=181, 58, 180, 59, 55, 172, 61) | 2.01 percent change | Standard Deviation 3.316 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit | Month 6 (n=189, 62, 194, 61, 59, 180, 63) | 1.10 percent change | Standard Deviation 2.782 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit | Month 12 (n=181, 58, 180, 59, 55, 172, 61) | 1.32 percent change | Standard Deviation 3.399 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit | Month 6 (n=189, 62, 194, 61, 59, 180, 63) | 0.91 percent change | Standard Deviation 2.665 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit | End of Study (n=189, 62, 194, 61, 59, 180, 63) | 1.30 percent change | Standard Deviation 3.309 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit | End of Study (n=189, 62, 194, 61, 59, 180, 63) | 0.89 percent change | Standard Deviation 3.172 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit | Month 6 (n=189, 62, 194, 61, 59, 180, 63) | 0.43 percent change | Standard Deviation 2.666 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit | Month 12 (n=181, 58, 180, 59, 55, 172, 61) | 0.95 percent change | Standard Deviation 3.233 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit | Month 12 (n=181, 58, 180, 59, 55, 172, 61) | 1.15 percent change | Standard Deviation 3.182 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit | Month 6 (n=189, 62, 194, 61, 59, 180, 63) | 0.54 percent change | Standard Deviation 2.404 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit | End of Study (n=189, 62, 194, 61, 59, 180, 63) | 1.15 percent change | Standard Deviation 3.131 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit | Month 12 (n=181, 58, 180, 59, 55, 172, 61) | 1.38 percent change | Standard Deviation 3.013 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit | Month 6 (n=189, 62, 194, 61, 59, 180, 63) | 0.77 percent change | Standard Deviation 2.401 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit | End of Study (n=189, 62, 194, 61, 59, 180, 63) | 1.33 percent change | Standard Deviation 2.948 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit | Month 6 (n=189, 62, 194, 61, 59, 180, 63) | 0.78 percent change | Standard Deviation 2.42 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit | End of Study (n=189, 62, 194, 61, 59, 180, 63) | 1.45 percent change | Standard Deviation 2.565 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit | Month 12 (n=181, 58, 180, 59, 55, 172, 61) | 1.45 percent change | Standard Deviation 2.58 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit | End of Study (n=189, 62, 194, 61, 59, 180, 63) | 1.39 percent change | Standard Deviation 2.873 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit | Month 12 (n=181, 58, 180, 59, 55, 172, 61) | 1.48 percent change | Standard Deviation 2.88 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Femur (Total Proximal Femur) BMD Measured by DXA at Each Visit | Month 6 (n=189, 62, 194, 61, 59, 180, 63) | 0.55 percent change | Standard Deviation 2.39 |
Secondary
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.
Time frame: Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
Population: FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit | End of Study (n=189, 62, 194, 61, 59, 180, 63) | 2.52 percent change | Standard Deviation 5.938 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit | Month 12 (n=181, 58, 180, 59, 55, 172, 61) | 2.59 percent change | Standard Deviation 6.007 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit | Month 6 (n=189, 62, 194, 61, 59, 180, 63) | 1.34 percent change | Standard Deviation 4.854 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit | Month 12 (n=181, 58, 180, 59, 55, 172, 61) | 1.80 percent change | Standard Deviation 4.03 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit | Month 6 (n=189, 62, 194, 61, 59, 180, 63) | 1.57 percent change | Standard Deviation 3.832 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit | End of Study (n=189, 62, 194, 61, 59, 180, 63) | 1.67 percent change | Standard Deviation 3.951 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit | End of Study (n=189, 62, 194, 61, 59, 180, 63) | 1.35 percent change | Standard Deviation 4.551 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit | Month 6 (n=189, 62, 194, 61, 59, 180, 63) | 0.70 percent change | Standard Deviation 4.324 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit | Month 12 (n=181, 58, 180, 59, 55, 172, 61) | 1.36 percent change | Standard Deviation 4.632 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit | Month 12 (n=181, 58, 180, 59, 55, 172, 61) | 1.66 percent change | Standard Deviation 4.095 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit | Month 6 (n=189, 62, 194, 61, 59, 180, 63) | 0.80 percent change | Standard Deviation 3.5 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit | End of Study (n=189, 62, 194, 61, 59, 180, 63) | 1.64 percent change | Standard Deviation 4.038 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit | Month 12 (n=181, 58, 180, 59, 55, 172, 61) | 2.47 percent change | Standard Deviation 4.129 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit | Month 6 (n=189, 62, 194, 61, 59, 180, 63) | 1.46 percent change | Standard Deviation 3.495 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit | End of Study (n=189, 62, 194, 61, 59, 180, 63) | 2.42 percent change | Standard Deviation 4.005 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit | Month 6 (n=189, 62, 194, 61, 59, 180, 63) | 1.09 percent change | Standard Deviation 3.141 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit | End of Study (n=189, 62, 194, 61, 59, 180, 63) | 1.94 percent change | Standard Deviation 3.661 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit | Month 12 (n=181, 58, 180, 59, 55, 172, 61) | 1.94 percent change | Standard Deviation 3.722 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit | End of Study (n=189, 62, 194, 61, 59, 180, 63) | 1.85 percent change | Standard Deviation 4.203 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit | Month 12 (n=181, 58, 180, 59, 55, 172, 61) | 1.90 percent change | Standard Deviation 4.259 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Femur (Trochanter) BMD Measured by DXA at Each Visit | Month 6 (n=189, 62, 194, 61, 59, 180, 63) | 0.53 percent change | Standard Deviation 4.432 |
Secondary
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.
Time frame: Baseline and Month 6, Month 12, and End of Study (Last observation carried forward at Month 12)
Population: FAS, all randomized participants who received at least 1 dose of study drug, with data available for analyses. n in the category is the number of participants with data available at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit | End of Study (n=190, 62, 194, 61, 59, 181, 63) | 5.07 percent change | Standard Deviation 4.749 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit | Month 12 (n=178, 58, 180, 58, 55, 171, 60) | 5.00 percent change | Standard Deviation 4.783 |
| NE-58095 IR 2.5 mg Once Daily on Awakening | Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit | Month 6 (n=190, 62, 194, 61, 59, 181, 63) | 3.18 percent change | Standard Deviation 4.211 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit | End of Study (n=190, 62, 194, 61, 59, 181, 63) | 3.82 percent change | Standard Deviation 4.158 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit | Month 12 (n=178, 58, 180, 58, 55, 171, 60) | 3.83 percent change | Standard Deviation 4.227 |
| NE-58095 DR 25 mg Once Monthly Following Breakfast | Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit | Month 6 (n=190, 62, 194, 61, 59, 181, 63) | 1.73 percent change | Standard Deviation 3.635 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit | End of Study (n=190, 62, 194, 61, 59, 181, 63) | 3.36 percent change | Standard Deviation 4.332 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit | Month 12 (n=178, 58, 180, 58, 55, 171, 60) | 3.53 percent change | Standard Deviation 4.423 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit | Month 6 (n=190, 62, 194, 61, 59, 181, 63) | 1.92 percent change | Standard Deviation 4.124 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit | End of Study (n=190, 62, 194, 61, 59, 181, 63) | 3.93 percent change | Standard Deviation 3.714 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit | Month 6 (n=190, 62, 194, 61, 59, 181, 63) | 2.40 percent change | Standard Deviation 3.408 |
| NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit | Month 12 (n=178, 58, 180, 58, 55, 171, 60) | 3.98 percent change | Standard Deviation 3.784 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit | Month 12 (n=178, 58, 180, 58, 55, 171, 60) | 5.04 percent change | Standard Deviation 4.387 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit | End of Study (n=190, 62, 194, 61, 59, 181, 63) | 4.81 percent change | Standard Deviation 4.383 |
| NE-58095 DR 37.5 mg Once Monthly on Awakening | Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit | Month 6 (n=190, 62, 194, 61, 59, 181, 63) | 3.67 percent change | Standard Deviation 4.841 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit | End of Study (n=190, 62, 194, 61, 59, 181, 63) | 4.11 percent change | Standard Deviation 4.654 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit | Month 6 (n=190, 62, 194, 61, 59, 181, 63) | 2.70 percent change | Standard Deviation 4.117 |
| NE-58095 DR 37.5 mg Once Monthly Following Breakfast | Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit | Month 12 (n=178, 58, 180, 58, 55, 171, 60) | 4.05 percent change | Standard Deviation 4.518 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit | Month 12 (n=178, 58, 180, 58, 55, 171, 60) | 4.38 percent change | Standard Deviation 5.277 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit | Month 6 (n=190, 62, 194, 61, 59, 181, 63) | 2.64 percent change | Standard Deviation 4.907 |
| NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast | Percent Change From Baseline in Mean Lumbar Spine (L2-L4) BMD Measured by DXA at Each Visit | End of Study (n=190, 62, 194, 61, 59, 181, 63) | 4.36 percent change | Standard Deviation 5.15 |