Growth and Development
Conditions
Brief summary
To investigate the effect of nutritional supplement on bone turnover markers (which are sensitive and respond quickly to nutrition or drug intervention) in Indian healthy premenopausal women after 6 months of intervention.
Detailed description
This will be a double blind, single-center, randomized-controlled trial testing the effect of fortified beverage on bone turnover markers as compared to placebo control in 25-45 years old premenopausal women. The study will consist of two groups: Group 1 (Test) - Protein rich beverage powder fortified with MMN and Group 2 (control) - Low protein non-fortified iso-caloric beverage powder.
Interventions
DIETARY_SUPPLEMENTFortified Beverage Powder
The tumbler will be filled with water up to the 200 mL mark. The entire contents of one sachet (Fortified beverage powder) will be gradually emptied in the tumbler with intermittent stirring to avoid formation of lumps. The reconstituted product will be consumed by the participants immediately orally.
DIETARY_SUPPLEMENTNon fortified beverage Powder
The tumbler will be filled with water up to the 200 mL mark. The entire contents of one sachet (Non fortified beverage powder) will be gradually emptied in the tumbler with intermittent stirring to avoid formation of lumps. The reconstituted product will be consumed by the participants immediately orally.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form. * Female Participants. * Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination. * BMI between 18.0-30 (kg/m2, Kilograms Per Meter Square) inclusive. * Women who understand, willing, able and likely to comply with all study procedures and restrictions.
Exclusion criteria
* Women who are known to be pregnant or who are intending to become pregnant over the duration of the study or Women who have a positive urine pregnancy test. * Women who have attained physiological menopause defined as those who have not had a menstrual period for consecutive 12 months. * Women who are breast-feeding. * Current (within 14 days of the start of the study) or regular use of any prescription, over the counter (OTC), vitamin supplements herbal medicine unless the medication has been approved by the study physician. * Treatment with bisphosphonates (any dose within the previous 2 years) or other medications known to affect bone (within the previous 6 months). * History of metabolic bone disease. * Any hormonal disorders or disturbances. * Bone fracture in last 12 months. * Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. * Participant is lactose intolerant. * Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit. * Previous participation in this study. * Recent history (within the last 1 year) of alcohol or other substance abuse. * More than 2 Units of alcohol per day * Smokers * Currently taking any other health food drinks/beverages or supplements (including nutritional supplements e.g. multivitamins and/or herbal supplements e.g. ginkgo) or has been on supplements within a month prior to study start. * Women who used medication known to influence bone mass and the use of calcium, vitamin D, and multivitamin supplements on a regular basis were stopped 2 months before the onset of the trial. * An employee of the sponsor or the study site or members of their immediate family. * Ongoing conditions known to cause abnormalities of calcium metabolism or skeletal health, malabsorption syndromes (such as coeliac or Crohn's disease), hyperthyroidism, hyperparathyroidism, hypo- or hypercalcaemia, osteomalacia, Paget's disease, and diabetes. * Fracture in the past 12 months. * Known chronic kidney disease or alcoholism. * Obesity women ( Body Mass Index, BMI\>30) and Thinness i.e. BMI\<18 kg/m2 * Severely anemic (Hemoglobin, Hb\<8 g/dl, Grams Per Decilitre). * Undertaking excessive exercise (\>2 strenuous\* exercise sessions per week) * Contraceptive injections within the previous year. * Known histories of surgeries such as bilateral oophrectomy (surgical removal of ovaries) * Diagnosed hypogondal states such as Turner syndrome, Klinfelter syndrome, Kallman * syndrome, anorexia nervosa, hypothalamic amenorrhea or hyperprolactinemia * Hemotological disorders e.g. Hemophilia, Leukemia and lymphomas monoclonal multiple myeloma, sickle cell disease, Thalassemia etc. * Rheumatological and autoimmune disorders such as ankylosing spondylitis, rheumatoid arthritis, systemic lupus etc. * Miscellaneous conditions and diseases such as Human Immunodeficiency Virus/acquired immunodeficiency syndrome (HIV/AIDS), alcoholism, amyloidosis, chronic metabolic acidosis, Chronic Obstructive Pulmonary Disease (COPD), congestive heart failure, depression etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 6 Months | At baseline and at 6 months | s-CTX-1 is a bone resorption marker which is used to assess the bone health. After 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. CTX-1 serum was analysed using biochemical tests from the samples stored. Decreased s-CTX-1 is associated with improved bone health. |
| Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 6 Months | At baseline and 6 months | c-OC/ uc-OC is considered as a surrogate marker of bone formation which is used to assess the bone health. After 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. c-OC/ uc-OC levels were analysed using biochemical tests from the samples stored. Increased c-OC/ uc-OC is associated with improved bone health. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Urinary Cross Linking C-telopeptide of Type 1 Collagen at 3 Months and 6 Months | At baseline, at 3 and 6 months | Urinary-CTX-1 is a bone resorption surrogate marker which is used to assess the bone health. After 3 months and 6 months of taking the allocated product, spot urinary sample were collected. CTX-1 urine levels were analysed using biochemical tests from the samples stored. Decreased urinary CTX-1 is associated with improved bone health. |
| Change From Baseline in Serum N-terminal Telopeptide of Type 1 Collagen (s-NTX-1) at 3 Months and 6 Months | At baseline, at 3 months and 6 months | NTX-1 is a bone resorption surrogate marker which is used to assess the bone health. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. NTX-1 serum was analysed using biochemical tests from the samples stored. Decreased s-NTX-1 is associated with improved bone health. The unit of measurement is nanomole bone collagen equivalent (NM BCE). |
| Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (s-P1NP) at 3 Months and 6 Months | At baseline, at 3 months and 6 months | P1NP is a bone formation surrogate marker which is used to assess the bone health being the most abundant protein of bone matrix. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. P1NP serum was analysed using biochemical tests from the samples stored. Increased s-P1NP is associated with improved bone health. |
| Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at 3 Months and 6 Months | At baseline, at 3 months and 6 months | BSAP is a bone formation surrogate marker which is used to assess the bone health. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. BSAP serum was analysed using biochemical tests from the samples stored. Increased s-BSAP is associated with improved bone health. |
| Change From Baseline in Serum Parathyroid Hormone (s-PTH) at 3 Months and 6 Months | At baseline, at 3 months and 6 months | PTH is used to compare calcium concentration status which defines the healthy bones. Intact PTH is the biologically active form and is secreted when the calcium level is low. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. PTH serum was analysed using biochemical tests from the samples stored. Decreased s-PTH is associated with improved bone health. |
| Change From Baseline in Urinary Calcium at 3 Months and 6 Months | At baseline, at 3 months and 6 months | Urinary calcium is used to compare calcium concentration status which defines the healthy bones. After 3 months and 6 months of taking the allocated product, spot urinary sample were collected. Urinary calcium was analysed using biochemical tests from the samples stored. Decreased urinary calcium is associated with improved bone health. |
| Change From Baseline in Serum Calcium at 3 Months and 6 Months | At baseline, at 3 months and 6 months | Serum calcium is used to compare calcium concentration status which defines the healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum calcium was analysed using biochemical tests from the samples stored. Increased serum calcium is associated with improved bone health. |
| Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 3 Months | At baseline and at 3 months | s-CTX-1 is a bone resorption marker which is used to assess the bone health. After 3 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. CTX-1 serum was analysed using biochemical tests from the samples stored. Decreased s-CTX-1 is associated with improved bone health. |
| Change From Baseline in Total Alkaline Phosphatase (ALP) at 3 Months and 6 Months | At baseline, at 3 months and 6 months | ALP is a diagnostic marker of which is used to assess bone mineral density for assessment of healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum ALP was analysed using biochemical tests from the samples stored. Increased serum ALP is associated with improved bone health. |
| Change From Baseline in Serum Vitamin D3 Using 25-hydroxycholecalciferol (25 OH D3) at 3 Months and 6 Months | At baseline, at 3 months and 6 months | Serum vitamin-D3 is used to analyse the status of vitamin-D profile which is necessary for healthy bones. The marker used for analyzing serum vitamin-D3 was 25 OH D3. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum vitamin-D3 was analysed using biochemical tests from the samples stored. Increased serum vitamin-D3 is associated with improved bone health. |
| Change From Baseline in Serum Selenium (Se) at 3 Months and 6 Months | At baseline, at 3 months and 6 months | Serum Se is used to assess the status of micronutrient profile necessary for healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum Se was analysed using biochemical tests from the samples stored. Increased serum Se is associated with improved bone health. |
| Change From Baseline in Plasma Zinc (Zn) at 3 Months and 6 Months | At baseline, at 3 months and 6 months | Plasma Zn is used to assess the status of micronutrient profile necessary for healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Plasma Zn was analysed using biochemical tests from the samples stored. Increased plasma Zn is associated with improved bone health. |
| Change From Baseline in Serum Folic Acid (Folate) at 3 Months and 6 Months | At baseline, at 3 months and 6 months | Serum folic acid (folate) is used to assess the status of micronutrient profile necessary for healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Plasma Zn was analysed using biochemical tests from the samples stored. Increased serum folate is associated with improved bone health. |
| Change From Baseline in Plasma Vitamin-B6 at 3 Months and 6 Months | At baseline, at 3 months and 6 months | Plasma vitamin-B6 is used to assess the status of micronutrient profile necessary for healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Plasma vitamin-B6 was analysed using biochemical tests from the samples stored. Increased plasma vitamin-B6 is associated with improved bone health. |
| Change From Baseline in Serum Vitamin-B12 at 3 Months and 6 Months | At baseline, at 3 months and 6 months | Serum vitamin-B12 is used to assess the status of micronutrient profile necessary for healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum vitamin-B12 was analysed using biochemical tests from the samples stored. Increased serum vitamin-B12 is associated with improved bone health. |
| Change From Baseline in Serum Phosphorus at 3 Months and 6 Months | At baseline, at 3 months and 6 months | Serum phosphorus is a diagnostic marker for assessment of healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum phosphorus was analysed using biochemical tests from the samples stored. Increased serum phosphorus is associated with improved bone health. |
| Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 3 Months | At baseline and at 3 months | c-OC/ uc-OC is considered as a surrogate marker of bone formation which is used to assess the bone health. After 3 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. c-OC/ uc-OC levels were analysed using biochemical tests from the samples stored. Increased c-OC/ uc-OC is associated with improved bone health. |
Countries
India
Participant flow
Recruitment details
Participants were recruited from one center in India.
Pre-assignment details
A total of 117 participates were screened, out of which 114 participants were enrolled and allocated to a randomized treatment in the study (57 participants in each group), and 3 participants were not randomized due to withdrawl of consent.
Participants by arm
| Arm | Count |
|---|---|
| Test Product Participants received the protein rich beverage powder fortified with multi-micronutrients (MMN). The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. | 57 |
| Reference Product Participants received the low protein non fortified isocaloric beverage powder. The dose was prepared by dissolving 30 grams (g) of powder in 200 milli-liters (mL) of water which was consumed orally twice-daily; morning and preferably in the evening, for 6 months. | 57 |
| Total | 114 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Withdrawal by Subject | 4 | 5 |
Baseline characteristics
| Characteristic | Reference Product | Total | Test Product |
|---|---|---|---|
| Age, Continuous | 34.2 Years STANDARD_DEVIATION 4.79 | 34.6 Years STANDARD_DEVIATION 4.6 | 35.0 Years STANDARD_DEVIATION 4.41 |
| Agr group Age 25- <35 years | 27 Participants | 53 Participants | 26 Participants |
| Agr group Age 35- <=45 years | 30 Participants | 61 Participants | 31 Participants |
| Body Mass Index | 25.0 Kilograms per meter squares (kg/m^2) STANDARD_DEVIATION 2.84 | 24.8 Kilograms per meter squares (kg/m^2) STANDARD_DEVIATION 2.9 | 24.7 Kilograms per meter squares (kg/m^2) STANDARD_DEVIATION 2.98 |
| Height | 154.1 Centimeters (cm) STANDARD_DEVIATION 5.27 | 153.4 Centimeters (cm) STANDARD_DEVIATION 5.12 | 152.8 Centimeters (cm) STANDARD_DEVIATION 4.92 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 57 Participants | 114 Participants | 57 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 57 Participants | 114 Participants | 57 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Weight | 59.6 Kilograms (kg) STANDARD_DEVIATION 8.52 | 58.5 Kilograms (kg) STANDARD_DEVIATION 7.89 | 57.5 Kilograms (kg) STANDARD_DEVIATION 7.14 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 57 |
| other Total, other adverse events | 19 / 57 | 19 / 57 |
| serious Total, serious adverse events | 0 / 57 | 0 / 57 |
Outcome results
Primary
Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 6 Months
s-CTX-1 is a bone resorption marker which is used to assess the bone health. After 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. CTX-1 serum was analysed using biochemical tests from the samples stored. Decreased s-CTX-1 is associated with improved bone health.
Time frame: At baseline and at 6 months
Population: The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 6 Months | At Baseline | 0.4440 Micrograms per litres (mcg/L) | Standard Deviation 0.11932 |
| Test Product | Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 6 Months | At 6 months | 0.2828 Micrograms per litres (mcg/L) | Standard Deviation 0.14218 |
| Test Product | Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 6 Months | Change from baseline at 6 months | -0.1612 Micrograms per litres (mcg/L) | Standard Deviation 0.15011 |
| Reference Product | Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 6 Months | At Baseline | 0.4410 Micrograms per litres (mcg/L) | Standard Deviation 0.16213 |
| Reference Product | Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 6 Months | At 6 months | 0.3245 Micrograms per litres (mcg/L) | Standard Deviation 0.16755 |
| Reference Product | Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 6 Months | Change from baseline at 6 months | -0.1165 Micrograms per litres (mcg/L) | Standard Deviation 0.16574 |
p-value: 0.132497.5% CI: [-0.1057, 0.0211]ANCOVA
Primary
Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 6 Months
c-OC/ uc-OC is considered as a surrogate marker of bone formation which is used to assess the bone health. After 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. c-OC/ uc-OC levels were analysed using biochemical tests from the samples stored. Increased c-OC/ uc-OC is associated with improved bone health.
Time frame: At baseline and 6 months
Population: The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 6 Months | At baseline | 1.208 Ratio | Standard Deviation 0.7573 |
| Test Product | Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 6 Months | At 6 months | 1.492 Ratio | Standard Deviation 0.6666 |
| Test Product | Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 6 Months | Change from baseline at 6 months | 0.284 Ratio | Standard Deviation 0.8961 |
| Reference Product | Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 6 Months | At baseline | 1.138 Ratio | Standard Deviation 0.6747 |
| Reference Product | Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 6 Months | At 6 months | 1.251 Ratio | Standard Deviation 0.4858 |
| Reference Product | Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 6 Months | Change from baseline at 6 months | 0.113 Ratio | Standard Deviation 0.716 |
p-value: 0.046997.5% CI: [-0.03, 0.489]ANCOVA
Secondary
Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at 3 Months and 6 Months
BSAP is a bone formation surrogate marker which is used to assess the bone health. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. BSAP serum was analysed using biochemical tests from the samples stored. Increased s-BSAP is associated with improved bone health.
Time frame: At baseline, at 3 months and 6 months
Population: The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at 3 Months and 6 Months | At 3 months | 9.441 mcg/L | Standard Deviation 4.3417 |
| Test Product | Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at 3 Months and 6 Months | At 6 months | 10.013 mcg/L | Standard Deviation 3.3193 |
| Test Product | Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at 3 Months and 6 Months | Change from baseline at 3 months | -1.649 mcg/L | Standard Deviation 1.8695 |
| Test Product | Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at 3 Months and 6 Months | Change from baseline at 6 months | -1.058 mcg/L | Standard Deviation 4.167 |
| Test Product | Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at 3 Months and 6 Months | At baseline | 11.071 mcg/L | Standard Deviation 4.1076 |
| Reference Product | Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at 3 Months and 6 Months | Change from baseline at 6 months | 0.980 mcg/L | Standard Deviation 1.4648 |
| Reference Product | Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at 3 Months and 6 Months | At baseline | 10.774 mcg/L | Standard Deviation 3.0623 |
| Reference Product | Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at 3 Months and 6 Months | At 3 months | 10.188 mcg/L | Standard Deviation 3.081 |
| Reference Product | Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at 3 Months and 6 Months | Change from baseline at 3 months | -0.586 mcg/L | Standard Deviation 1.7019 |
| Reference Product | Change From Baseline in Bone Specific Alkaline Phosphatase (BSAP) at 3 Months and 6 Months | At 6 months | 11.754 mcg/L | Standard Deviation 3.3887 |
Secondary
Change From Baseline in Plasma Vitamin-B6 at 3 Months and 6 Months
Plasma vitamin-B6 is used to assess the status of micronutrient profile necessary for healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Plasma vitamin-B6 was analysed using biochemical tests from the samples stored. Increased plasma vitamin-B6 is associated with improved bone health.
Time frame: At baseline, at 3 months and 6 months
Population: The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | Change From Baseline in Plasma Vitamin-B6 at 3 Months and 6 Months | At 3 months | 32.9 nmol/L | Standard Deviation 22.59 |
| Test Product | Change From Baseline in Plasma Vitamin-B6 at 3 Months and 6 Months | At 6 months | 32.6 nmol/L | Standard Deviation 19.76 |
| Test Product | Change From Baseline in Plasma Vitamin-B6 at 3 Months and 6 Months | At baseline | 23.6 nmol/L | Standard Deviation 16.11 |
| Test Product | Change From Baseline in Plasma Vitamin-B6 at 3 Months and 6 Months | Change from baseline at 6 months | 8.9 nmol/L | Standard Deviation 25.01 |
| Test Product | Change From Baseline in Plasma Vitamin-B6 at 3 Months and 6 Months | Change from baseline at 3 months | 10.3 nmol/L | Standard Deviation 25.75 |
| Reference Product | Change From Baseline in Plasma Vitamin-B6 at 3 Months and 6 Months | Change from baseline at 6 months | -3.1 nmol/L | Standard Deviation 10.96 |
| Reference Product | Change From Baseline in Plasma Vitamin-B6 at 3 Months and 6 Months | At 3 months | 22.4 nmol/L | Standard Deviation 37.39 |
| Reference Product | Change From Baseline in Plasma Vitamin-B6 at 3 Months and 6 Months | Change from baseline at 3 months | -0.5 nmol/L | Standard Deviation 35.7 |
| Reference Product | Change From Baseline in Plasma Vitamin-B6 at 3 Months and 6 Months | At 6 months | 19.4 nmol/L | Standard Deviation 12.08 |
| Reference Product | Change From Baseline in Plasma Vitamin-B6 at 3 Months and 6 Months | At baseline | 22.4 nmol/L | Standard Deviation 13.83 |
Secondary
Change From Baseline in Plasma Zinc (Zn) at 3 Months and 6 Months
Plasma Zn is used to assess the status of micronutrient profile necessary for healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Plasma Zn was analysed using biochemical tests from the samples stored. Increased plasma Zn is associated with improved bone health.
Time frame: At baseline, at 3 months and 6 months
Population: The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | Change From Baseline in Plasma Zinc (Zn) at 3 Months and 6 Months | At 3 months | 10.28 mcmol/L | Standard Deviation 1.758 |
| Test Product | Change From Baseline in Plasma Zinc (Zn) at 3 Months and 6 Months | At 6 months | 10.33 mcmol/L | Standard Deviation 1.324 |
| Test Product | Change From Baseline in Plasma Zinc (Zn) at 3 Months and 6 Months | Change from baseline at 3 months | -0.47 mcmol/L | Standard Deviation 1.988 |
| Test Product | Change From Baseline in Plasma Zinc (Zn) at 3 Months and 6 Months | Change from baseline at 6 months | -0.43 mcmol/L | Standard Deviation 2.066 |
| Test Product | Change From Baseline in Plasma Zinc (Zn) at 3 Months and 6 Months | At baseline | 10.75 mcmol/L | Standard Deviation 1.746 |
| Reference Product | Change From Baseline in Plasma Zinc (Zn) at 3 Months and 6 Months | Change from baseline at 6 months | -0.60 mcmol/L | Standard Deviation 2.241 |
| Reference Product | Change From Baseline in Plasma Zinc (Zn) at 3 Months and 6 Months | At baseline | 10.64 mcmol/L | Standard Deviation 2.071 |
| Reference Product | Change From Baseline in Plasma Zinc (Zn) at 3 Months and 6 Months | At 3 months | 10.05 mcmol/L | Standard Deviation 1.54 |
| Reference Product | Change From Baseline in Plasma Zinc (Zn) at 3 Months and 6 Months | Change from baseline at 3 months | -0.61 mcmol/L | Standard Deviation 2.234 |
| Reference Product | Change From Baseline in Plasma Zinc (Zn) at 3 Months and 6 Months | At 6 months | 10.00 mcmol/L | Standard Deviation 1.562 |
Secondary
Change From Baseline in Serum Calcium at 3 Months and 6 Months
Serum calcium is used to compare calcium concentration status which defines the healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum calcium was analysed using biochemical tests from the samples stored. Increased serum calcium is associated with improved bone health.
Time frame: At baseline, at 3 months and 6 months
Population: The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | Change From Baseline in Serum Calcium at 3 Months and 6 Months | At baseline | 2.299 Millimoles per liter (mmol/L) | Standard Deviation 0.0629 |
| Test Product | Change From Baseline in Serum Calcium at 3 Months and 6 Months | At 6 months | 2.359 Millimoles per liter (mmol/L) | Standard Deviation 0.0835 |
| Test Product | Change From Baseline in Serum Calcium at 3 Months and 6 Months | At 3 months | 2.266 Millimoles per liter (mmol/L) | Standard Deviation 0.0778 |
| Test Product | Change From Baseline in Serum Calcium at 3 Months and 6 Months | Change from baseline at 6 months | 0.060 Millimoles per liter (mmol/L) | Standard Deviation 0.0873 |
| Test Product | Change From Baseline in Serum Calcium at 3 Months and 6 Months | Change from baseline at 3 months | -0.038 Millimoles per liter (mmol/L) | Standard Deviation 0.0854 |
| Reference Product | Change From Baseline in Serum Calcium at 3 Months and 6 Months | Change from baseline at 6 months | 0.030 Millimoles per liter (mmol/L) | Standard Deviation 0.0821 |
| Reference Product | Change From Baseline in Serum Calcium at 3 Months and 6 Months | At baseline | 2.296 Millimoles per liter (mmol/L) | Standard Deviation 0.0703 |
| Reference Product | Change From Baseline in Serum Calcium at 3 Months and 6 Months | Change from baseline at 3 months | -0.037 Millimoles per liter (mmol/L) | Standard Deviation 0.0825 |
| Reference Product | Change From Baseline in Serum Calcium at 3 Months and 6 Months | At 6 months | 2.326 Millimoles per liter (mmol/L) | Standard Deviation 0.0792 |
| Reference Product | Change From Baseline in Serum Calcium at 3 Months and 6 Months | At 3 months | 2.258 Millimoles per liter (mmol/L) | Standard Deviation 0.0862 |
Secondary
Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 3 Months
s-CTX-1 is a bone resorption marker which is used to assess the bone health. After 3 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. CTX-1 serum was analysed using biochemical tests from the samples stored. Decreased s-CTX-1 is associated with improved bone health.
Time frame: At baseline and at 3 months
Population: The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 3 Months | At baseline | 0.4440 mcg/L | Standard Deviation 0.11932 |
| Test Product | Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 3 Months | At 3 months | 0.2996 mcg/L | Standard Deviation 0.15762 |
| Test Product | Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 3 Months | Change from baseline at 3 months | -0.1444 mcg/L | Standard Deviation 0.14563 |
| Reference Product | Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 3 Months | At baseline | 0.4410 mcg/L | Standard Deviation 0.16213 |
| Reference Product | Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 3 Months | At 3 months | 0.3302 mcg/L | Standard Deviation 0.16693 |
| Reference Product | Change From Baseline in Serum Cross Linking C-telopeptide of Type 1 Collagen (s-CTX-1) at 3 Months | Change from baseline at 3 months | -0.1108 mcg/L | Standard Deviation 0.13265 |
Secondary
Change From Baseline in Serum Folic Acid (Folate) at 3 Months and 6 Months
Serum folic acid (folate) is used to assess the status of micronutrient profile necessary for healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Plasma Zn was analysed using biochemical tests from the samples stored. Increased serum folate is associated with improved bone health.
Time frame: At baseline, at 3 months and 6 months
Population: The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | Change From Baseline in Serum Folic Acid (Folate) at 3 Months and 6 Months | At 3 months | 26.40 nmol/L | Standard Deviation 25.768 |
| Test Product | Change From Baseline in Serum Folic Acid (Folate) at 3 Months and 6 Months | At 6 months | 43.93 nmol/L | Standard Deviation 135.047 |
| Test Product | Change From Baseline in Serum Folic Acid (Folate) at 3 Months and 6 Months | Change from baseline at 3 months | 7.72 nmol/L | Standard Deviation 27.996 |
| Test Product | Change From Baseline in Serum Folic Acid (Folate) at 3 Months and 6 Months | Change from baseline at 6 months | 24.94 nmol/L | Standard Deviation 137.118 |
| Test Product | Change From Baseline in Serum Folic Acid (Folate) at 3 Months and 6 Months | At baseline | 18.84 nmol/L | Standard Deviation 13.57 |
| Reference Product | Change From Baseline in Serum Folic Acid (Folate) at 3 Months and 6 Months | Change from baseline at 6 months | -23.82 nmol/L | Standard Deviation 137.006 |
| Reference Product | Change From Baseline in Serum Folic Acid (Folate) at 3 Months and 6 Months | At baseline | 39.74 nmol/L | Standard Deviation 138.032 |
| Reference Product | Change From Baseline in Serum Folic Acid (Folate) at 3 Months and 6 Months | At 3 months | 15.09 nmol/L | Standard Deviation 7.43 |
| Reference Product | Change From Baseline in Serum Folic Acid (Folate) at 3 Months and 6 Months | Change from baseline at 3 months | -27.05 nmol/L | Standard Deviation 139.528 |
| Reference Product | Change From Baseline in Serum Folic Acid (Folate) at 3 Months and 6 Months | At 6 months | 16.27 nmol/L | Standard Deviation 6.496 |
Secondary
Change From Baseline in Serum N-terminal Telopeptide of Type 1 Collagen (s-NTX-1) at 3 Months and 6 Months
NTX-1 is a bone resorption surrogate marker which is used to assess the bone health. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. NTX-1 serum was analysed using biochemical tests from the samples stored. Decreased s-NTX-1 is associated with improved bone health. The unit of measurement is nanomole bone collagen equivalent (NM BCE).
Time frame: At baseline, at 3 months and 6 months
Population: The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | Change From Baseline in Serum N-terminal Telopeptide of Type 1 Collagen (s-NTX-1) at 3 Months and 6 Months | At 3 months | 10.68 NM BCE | Standard Deviation 6.315 |
| Test Product | Change From Baseline in Serum N-terminal Telopeptide of Type 1 Collagen (s-NTX-1) at 3 Months and 6 Months | At 6 months | 8.22 NM BCE | Standard Deviation 3.146 |
| Test Product | Change From Baseline in Serum N-terminal Telopeptide of Type 1 Collagen (s-NTX-1) at 3 Months and 6 Months | Change from baseline at 3 months | -0.97 NM BCE | Standard Deviation 6.466 |
| Test Product | Change From Baseline in Serum N-terminal Telopeptide of Type 1 Collagen (s-NTX-1) at 3 Months and 6 Months | Change from baseline at 6 months | -3.43 NM BCE | Standard Deviation 4.072 |
| Test Product | Change From Baseline in Serum N-terminal Telopeptide of Type 1 Collagen (s-NTX-1) at 3 Months and 6 Months | At baseline | 11.64 NM BCE | Standard Deviation 3.373 |
| Reference Product | Change From Baseline in Serum N-terminal Telopeptide of Type 1 Collagen (s-NTX-1) at 3 Months and 6 Months | Change from baseline at 6 months | -2.49 NM BCE | Standard Deviation 4.296 |
| Reference Product | Change From Baseline in Serum N-terminal Telopeptide of Type 1 Collagen (s-NTX-1) at 3 Months and 6 Months | At baseline | 11.87 NM BCE | Standard Deviation 3.093 |
| Reference Product | Change From Baseline in Serum N-terminal Telopeptide of Type 1 Collagen (s-NTX-1) at 3 Months and 6 Months | At 3 months | 10.00 NM BCE | Standard Deviation 5.72 |
| Reference Product | Change From Baseline in Serum N-terminal Telopeptide of Type 1 Collagen (s-NTX-1) at 3 Months and 6 Months | Change from baseline at 3 months | -1.99 NM BCE | Standard Deviation 5.861 |
| Reference Product | Change From Baseline in Serum N-terminal Telopeptide of Type 1 Collagen (s-NTX-1) at 3 Months and 6 Months | At 6 months | 9.38 NM BCE | Standard Deviation 4.157 |
Secondary
Change From Baseline in Serum Parathyroid Hormone (s-PTH) at 3 Months and 6 Months
PTH is used to compare calcium concentration status which defines the healthy bones. Intact PTH is the biologically active form and is secreted when the calcium level is low. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. PTH serum was analysed using biochemical tests from the samples stored. Decreased s-PTH is associated with improved bone health.
Time frame: At baseline, at 3 months and 6 months
Population: The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | Change From Baseline in Serum Parathyroid Hormone (s-PTH) at 3 Months and 6 Months | Change from baseline at 3 months | -0.66 Picomole per liter (pmol/L) | Standard Deviation 2.798 |
| Test Product | Change From Baseline in Serum Parathyroid Hormone (s-PTH) at 3 Months and 6 Months | Change from baseline at 6 months | 1.53 Picomole per liter (pmol/L) | Standard Deviation 3.126 |
| Test Product | Change From Baseline in Serum Parathyroid Hormone (s-PTH) at 3 Months and 6 Months | At 6 months | 7.27 Picomole per liter (pmol/L) | Standard Deviation 3.429 |
| Test Product | Change From Baseline in Serum Parathyroid Hormone (s-PTH) at 3 Months and 6 Months | At baseline | 5.73 Picomole per liter (pmol/L) | Standard Deviation 2.875 |
| Test Product | Change From Baseline in Serum Parathyroid Hormone (s-PTH) at 3 Months and 6 Months | At 3 months | 4.99 Picomole per liter (pmol/L) | Standard Deviation 3.394 |
| Reference Product | Change From Baseline in Serum Parathyroid Hormone (s-PTH) at 3 Months and 6 Months | At baseline | 5.35 Picomole per liter (pmol/L) | Standard Deviation 2.499 |
| Reference Product | Change From Baseline in Serum Parathyroid Hormone (s-PTH) at 3 Months and 6 Months | At 3 months | 5.75 Picomole per liter (pmol/L) | Standard Deviation 2.602 |
| Reference Product | Change From Baseline in Serum Parathyroid Hormone (s-PTH) at 3 Months and 6 Months | Change from baseline at 3 months | 0.34 Picomole per liter (pmol/L) | Standard Deviation 2.479 |
| Reference Product | Change From Baseline in Serum Parathyroid Hormone (s-PTH) at 3 Months and 6 Months | At 6 months | 8.09 Picomole per liter (pmol/L) | Standard Deviation 4.303 |
| Reference Product | Change From Baseline in Serum Parathyroid Hormone (s-PTH) at 3 Months and 6 Months | Change from baseline at 6 months | 2.69 Picomole per liter (pmol/L) | Standard Deviation 4.143 |
Secondary
Change From Baseline in Serum Phosphorus at 3 Months and 6 Months
Serum phosphorus is a diagnostic marker for assessment of healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum phosphorus was analysed using biochemical tests from the samples stored. Increased serum phosphorus is associated with improved bone health.
Time frame: At baseline, at 3 months and 6 months
Population: The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | Change From Baseline in Serum Phosphorus at 3 Months and 6 Months | At 3 months | 1.157 mmol/L | Standard Deviation 0.1879 |
| Test Product | Change From Baseline in Serum Phosphorus at 3 Months and 6 Months | At 6 months | 1.127 mmol/L | Standard Deviation 0.1493 |
| Test Product | Change From Baseline in Serum Phosphorus at 3 Months and 6 Months | Change from baseline at 3 months | 0.023 mmol/L | Standard Deviation 0.1832 |
| Test Product | Change From Baseline in Serum Phosphorus at 3 Months and 6 Months | Change from baseline at 6 months | -0.012 mmol/L | Standard Deviation 0.1617 |
| Test Product | Change From Baseline in Serum Phosphorus at 3 Months and 6 Months | At baseline | 1.138 mmol/L | Standard Deviation 0.1286 |
| Reference Product | Change From Baseline in Serum Phosphorus at 3 Months and 6 Months | Change from baseline at 6 months | -0.004 mmol/L | Standard Deviation 0.194 |
| Reference Product | Change From Baseline in Serum Phosphorus at 3 Months and 6 Months | At baseline | 1.127 mmol/L | Standard Deviation 0.1378 |
| Reference Product | Change From Baseline in Serum Phosphorus at 3 Months and 6 Months | At 3 months | 1.184 mmol/L | Standard Deviation 0.1621 |
| Reference Product | Change From Baseline in Serum Phosphorus at 3 Months and 6 Months | Change from baseline at 3 months | 0.062 mmol/L | Standard Deviation 0.158 |
| Reference Product | Change From Baseline in Serum Phosphorus at 3 Months and 6 Months | At 6 months | 1.123 mmol/L | Standard Deviation 0.181 |
Secondary
Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (s-P1NP) at 3 Months and 6 Months
P1NP is a bone formation surrogate marker which is used to assess the bone health being the most abundant protein of bone matrix. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. P1NP serum was analysed using biochemical tests from the samples stored. Increased s-P1NP is associated with improved bone health.
Time frame: At baseline, at 3 months and 6 months
Population: The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (s-P1NP) at 3 Months and 6 Months | At 6 months | 43.86 mcg/L | Standard Deviation 14.194 |
| Test Product | Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (s-P1NP) at 3 Months and 6 Months | Change from baseline at 6 months | -15.75 mcg/L | Standard Deviation 18.272 |
| Test Product | Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (s-P1NP) at 3 Months and 6 Months | At baseline | 59.61 mcg/L | Standard Deviation 22.044 |
| Test Product | Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (s-P1NP) at 3 Months and 6 Months | At 3 months | 46.64 mcg/L | Standard Deviation 17.982 |
| Test Product | Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (s-P1NP) at 3 Months and 6 Months | Change from baseline at 3 months | -12.96 mcg/L | Standard Deviation 15.929 |
| Reference Product | Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (s-P1NP) at 3 Months and 6 Months | Change from baseline at 3 months | -4.85 mcg/L | Standard Deviation 16.498 |
| Reference Product | Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (s-P1NP) at 3 Months and 6 Months | At 3 months | 54.22 mcg/L | Standard Deviation 20.592 |
| Reference Product | Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (s-P1NP) at 3 Months and 6 Months | Change from baseline at 6 months | -7.58 mcg/L | Standard Deviation 18.037 |
| Reference Product | Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (s-P1NP) at 3 Months and 6 Months | At 6 months | 51.12 mcg/L | Standard Deviation 22.586 |
| Reference Product | Change From Baseline in Serum Procollagen Type 1 N-terminal Propeptide (s-P1NP) at 3 Months and 6 Months | At baseline | 58.70 mcg/L | Standard Deviation 23.133 |
Secondary
Change From Baseline in Serum Selenium (Se) at 3 Months and 6 Months
Serum Se is used to assess the status of micronutrient profile necessary for healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum Se was analysed using biochemical tests from the samples stored. Increased serum Se is associated with improved bone health.
Time frame: At baseline, at 3 months and 6 months
Population: The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | Change From Baseline in Serum Selenium (Se) at 3 Months and 6 Months | At 3 months | 1.293 Micromole per liter (mcmol/L) | Standard Deviation 0.2153 |
| Test Product | Change From Baseline in Serum Selenium (Se) at 3 Months and 6 Months | At 6 months | 1.407 Micromole per liter (mcmol/L) | Standard Deviation 0.2773 |
| Test Product | Change From Baseline in Serum Selenium (Se) at 3 Months and 6 Months | Change from baseline at 3 months | -0.055 Micromole per liter (mcmol/L) | Standard Deviation 0.2447 |
| Test Product | Change From Baseline in Serum Selenium (Se) at 3 Months and 6 Months | Change from baseline at 6 months | 0.057 Micromole per liter (mcmol/L) | Standard Deviation 2.738 |
| Test Product | Change From Baseline in Serum Selenium (Se) at 3 Months and 6 Months | At baseline | 1.350 Micromole per liter (mcmol/L) | Standard Deviation 0.1702 |
| Reference Product | Change From Baseline in Serum Selenium (Se) at 3 Months and 6 Months | Change from baseline at 6 months | 0.031 Micromole per liter (mcmol/L) | Standard Deviation 0.2705 |
| Reference Product | Change From Baseline in Serum Selenium (Se) at 3 Months and 6 Months | At baseline | 1.305 Micromole per liter (mcmol/L) | Standard Deviation 0.1791 |
| Reference Product | Change From Baseline in Serum Selenium (Se) at 3 Months and 6 Months | At 3 months | 1.245 Micromole per liter (mcmol/L) | Standard Deviation 0.2875 |
| Reference Product | Change From Baseline in Serum Selenium (Se) at 3 Months and 6 Months | Change from baseline at 3 months | -0.076 Micromole per liter (mcmol/L) | Standard Deviation 0.2464 |
| Reference Product | Change From Baseline in Serum Selenium (Se) at 3 Months and 6 Months | At 6 months | 1.347 Micromole per liter (mcmol/L) | Standard Deviation 0.256 |
Secondary
Change From Baseline in Serum Vitamin-B12 at 3 Months and 6 Months
Serum vitamin-B12 is used to assess the status of micronutrient profile necessary for healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum vitamin-B12 was analysed using biochemical tests from the samples stored. Increased serum vitamin-B12 is associated with improved bone health.
Time frame: At baseline, at 3 months and 6 months
Population: The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | Change From Baseline in Serum Vitamin-B12 at 3 Months and 6 Months | At 3 months | 212.5 pmol/L | Standard Deviation 96.68 |
| Test Product | Change From Baseline in Serum Vitamin-B12 at 3 Months and 6 Months | At 6 months | 227.4 pmol/L | Standard Deviation 95.43 |
| Test Product | Change From Baseline in Serum Vitamin-B12 at 3 Months and 6 Months | Change from baseline at 3 months | 33.8 pmol/L | Standard Deviation 57.94 |
| Test Product | Change From Baseline in Serum Vitamin-B12 at 3 Months and 6 Months | Change from baseline at 6 months | 50.1 pmol/L | Standard Deviation 90.08 |
| Test Product | Change From Baseline in Serum Vitamin-B12 at 3 Months and 6 Months | At baseline | 177.1 pmol/L | Standard Deviation 75.1 |
| Reference Product | Change From Baseline in Serum Vitamin-B12 at 3 Months and 6 Months | Change from baseline at 6 months | -4.2 pmol/L | Standard Deviation 135.21 |
| Reference Product | Change From Baseline in Serum Vitamin-B12 at 3 Months and 6 Months | At baseline | 209.6 pmol/L | Standard Deviation 140.28 |
| Reference Product | Change From Baseline in Serum Vitamin-B12 at 3 Months and 6 Months | At 3 months | 190.2 pmol/L | Standard Deviation 76.99 |
| Reference Product | Change From Baseline in Serum Vitamin-B12 at 3 Months and 6 Months | Change from baseline at 3 months | -18.7 pmol/L | Standard Deviation 126.96 |
| Reference Product | Change From Baseline in Serum Vitamin-B12 at 3 Months and 6 Months | At 6 months | 205.4 pmol/L | Standard Deviation 91.7 |
Secondary
Change From Baseline in Serum Vitamin D3 Using 25-hydroxycholecalciferol (25 OH D3) at 3 Months and 6 Months
Serum vitamin-D3 is used to analyse the status of vitamin-D profile which is necessary for healthy bones. The marker used for analyzing serum vitamin-D3 was 25 OH D3. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum vitamin-D3 was analysed using biochemical tests from the samples stored. Increased serum vitamin-D3 is associated with improved bone health.
Time frame: At baseline, at 3 months and 6 months
Population: The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | Change From Baseline in Serum Vitamin D3 Using 25-hydroxycholecalciferol (25 OH D3) at 3 Months and 6 Months | At 3 months | 31.8 nmol/L | Standard Deviation 20.45 |
| Test Product | Change From Baseline in Serum Vitamin D3 Using 25-hydroxycholecalciferol (25 OH D3) at 3 Months and 6 Months | At 6 months | 30.5 nmol/L | Standard Deviation 21.78 |
| Test Product | Change From Baseline in Serum Vitamin D3 Using 25-hydroxycholecalciferol (25 OH D3) at 3 Months and 6 Months | Change from baseline at 3 months | -9.3 nmol/L | Standard Deviation 14.6 |
| Test Product | Change From Baseline in Serum Vitamin D3 Using 25-hydroxycholecalciferol (25 OH D3) at 3 Months and 6 Months | Change from baseline at 6 months | -13.9 nmol/L | Standard Deviation 27.51 |
| Test Product | Change From Baseline in Serum Vitamin D3 Using 25-hydroxycholecalciferol (25 OH D3) at 3 Months and 6 Months | At baseline | 44.4 nmol/L | Standard Deviation 36.78 |
| Reference Product | Change From Baseline in Serum Vitamin D3 Using 25-hydroxycholecalciferol (25 OH D3) at 3 Months and 6 Months | Change from baseline at 6 months | -7.0 nmol/L | Standard Deviation 20.36 |
| Reference Product | Change From Baseline in Serum Vitamin D3 Using 25-hydroxycholecalciferol (25 OH D3) at 3 Months and 6 Months | At baseline | 42.2 nmol/L | Standard Deviation 20.42 |
| Reference Product | Change From Baseline in Serum Vitamin D3 Using 25-hydroxycholecalciferol (25 OH D3) at 3 Months and 6 Months | At 3 months | 41.2 nmol/L | Standard Deviation 23.97 |
| Reference Product | Change From Baseline in Serum Vitamin D3 Using 25-hydroxycholecalciferol (25 OH D3) at 3 Months and 6 Months | Change from baseline at 3 months | -1.0 nmol/L | Standard Deviation 16.44 |
| Reference Product | Change From Baseline in Serum Vitamin D3 Using 25-hydroxycholecalciferol (25 OH D3) at 3 Months and 6 Months | At 6 months | 35.2 nmol/L | Standard Deviation 25.02 |
Secondary
Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 3 Months
c-OC/ uc-OC is considered as a surrogate marker of bone formation which is used to assess the bone health. After 3 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. c-OC/ uc-OC levels were analysed using biochemical tests from the samples stored. Increased c-OC/ uc-OC is associated with improved bone health.
Time frame: At baseline and at 3 months
Population: The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 3 Months | At baseline | 1.208 Ratio | Standard Deviation 0.7573 |
| Test Product | Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 3 Months | At 3 months | 1.706 Ratio | Standard Deviation 1.2083 |
| Test Product | Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 3 Months | Change from baseline at 3 months | 0.498 Ratio | Standard Deviation 1.3043 |
| Reference Product | Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 3 Months | At baseline | 1.138 Ratio | Standard Deviation 0.6747 |
| Reference Product | Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 3 Months | At 3 months | 1.192 Ratio | Standard Deviation 0.8305 |
| Reference Product | Change From Baseline in the Ratio of Carboxylated (c-OC) to Under-carboxylated Osteocalcin (Uc-OC) at 3 Months | Change from baseline at 3 months | 0.054 Ratio | Standard Deviation 0.8868 |
Secondary
Change From Baseline in Total Alkaline Phosphatase (ALP) at 3 Months and 6 Months
ALP is a diagnostic marker of which is used to assess bone mineral density for assessment of healthy bones. After 3 months and 6 months of taking the allocated product, blood sample was collected under 12-hour fasting condition. Blood serum of whole blood collected from each participant was then isolated by the method of centrifugation. Serum ALP was analysed using biochemical tests from the samples stored. Increased serum ALP is associated with improved bone health.
Time frame: At baseline, at 3 months and 6 months
Population: The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | Change From Baseline in Total Alkaline Phosphatase (ALP) at 3 Months and 6 Months | At 3 months | 63.3 Units per liter (U/L) | Standard Deviation 23.43 |
| Test Product | Change From Baseline in Total Alkaline Phosphatase (ALP) at 3 Months and 6 Months | At 6 months | 63.4 Units per liter (U/L) | Standard Deviation 20.26 |
| Test Product | Change From Baseline in Total Alkaline Phosphatase (ALP) at 3 Months and 6 Months | Change from baseline at 3 months | -5.9 Units per liter (U/L) | Standard Deviation 8.43 |
| Test Product | Change From Baseline in Total Alkaline Phosphatase (ALP) at 3 Months and 6 Months | Change from baseline at 6 months | -5.1 Units per liter (U/L) | Standard Deviation 19.15 |
| Test Product | Change From Baseline in Total Alkaline Phosphatase (ALP) at 3 Months and 6 Months | At baseline | 68.6 Units per liter (U/L) | Standard Deviation 25.94 |
| Reference Product | Change From Baseline in Total Alkaline Phosphatase (ALP) at 3 Months and 6 Months | Change from baseline at 6 months | -0.3 Units per liter (U/L) | Standard Deviation 9.44 |
| Reference Product | Change From Baseline in Total Alkaline Phosphatase (ALP) at 3 Months and 6 Months | At baseline | 70.4 Units per liter (U/L) | Standard Deviation 18.38 |
| Reference Product | Change From Baseline in Total Alkaline Phosphatase (ALP) at 3 Months and 6 Months | At 3 months | 67.7 Units per liter (U/L) | Standard Deviation 17.65 |
| Reference Product | Change From Baseline in Total Alkaline Phosphatase (ALP) at 3 Months and 6 Months | Change from baseline at 3 months | -2.3 Units per liter (U/L) | Standard Deviation 8.77 |
| Reference Product | Change From Baseline in Total Alkaline Phosphatase (ALP) at 3 Months and 6 Months | At 6 months | 70.2 Units per liter (U/L) | Standard Deviation 16.94 |
Secondary
Change From Baseline in Urinary Calcium at 3 Months and 6 Months
Urinary calcium is used to compare calcium concentration status which defines the healthy bones. After 3 months and 6 months of taking the allocated product, spot urinary sample were collected. Urinary calcium was analysed using biochemical tests from the samples stored. Decreased urinary calcium is associated with improved bone health.
Time frame: At baseline, at 3 months and 6 months
Population: The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | Change From Baseline in Urinary Calcium at 3 Months and 6 Months | At 3 months | 161.5 Millimoles per moles (mmol/mol) | Standard Deviation 142.6 |
| Test Product | Change From Baseline in Urinary Calcium at 3 Months and 6 Months | At 6 months | 338.3 Millimoles per moles (mmol/mol) | Standard Deviation 440.08 |
| Test Product | Change From Baseline in Urinary Calcium at 3 Months and 6 Months | Change from baseline at 3 months | 61.3 Millimoles per moles (mmol/mol) | Standard Deviation 126.75 |
| Test Product | Change From Baseline in Urinary Calcium at 3 Months and 6 Months | Change from baseline at 6 months | 235.3 Millimoles per moles (mmol/mol) | Standard Deviation 451.33 |
| Test Product | Change From Baseline in Urinary Calcium at 3 Months and 6 Months | At baseline | 104.5 Millimoles per moles (mmol/mol) | Standard Deviation 78.26 |
| Reference Product | Change From Baseline in Urinary Calcium at 3 Months and 6 Months | Change from baseline at 6 months | 448.9 Millimoles per moles (mmol/mol) | Standard Deviation 846.48 |
| Reference Product | Change From Baseline in Urinary Calcium at 3 Months and 6 Months | At baseline | 104.0 Millimoles per moles (mmol/mol) | Standard Deviation 82.26 |
| Reference Product | Change From Baseline in Urinary Calcium at 3 Months and 6 Months | At 3 months | 116.9 Millimoles per moles (mmol/mol) | Standard Deviation 131.53 |
| Reference Product | Change From Baseline in Urinary Calcium at 3 Months and 6 Months | Change from baseline at 3 months | 16.4 Millimoles per moles (mmol/mol) | Standard Deviation 98 |
| Reference Product | Change From Baseline in Urinary Calcium at 3 Months and 6 Months | At 6 months | 549.7 Millimoles per moles (mmol/mol) | Standard Deviation 851.54 |
Secondary
Change From Baseline in Urinary Cross Linking C-telopeptide of Type 1 Collagen at 3 Months and 6 Months
Urinary-CTX-1 is a bone resorption surrogate marker which is used to assess the bone health. After 3 months and 6 months of taking the allocated product, spot urinary sample were collected. CTX-1 urine levels were analysed using biochemical tests from the samples stored. Decreased urinary CTX-1 is associated with improved bone health.
Time frame: At baseline, at 3 and 6 months
Population: The Intent-to-Treat (ITT) population (n=102) was comprised of all randomized participants who received at least 1 dose of study treatment and had at least 1 post-baseline (post-treatment) primary efficacy evaluation. This population was based on the treatment to which the participant was randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Test Product | Change From Baseline in Urinary Cross Linking C-telopeptide of Type 1 Collagen at 3 Months and 6 Months | At baseline | 23.153 mcg/L | Standard Deviation 17.3511 |
| Test Product | Change From Baseline in Urinary Cross Linking C-telopeptide of Type 1 Collagen at 3 Months and 6 Months | At 3 months | 21.105 mcg/L | Standard Deviation 16.8386 |
| Test Product | Change From Baseline in Urinary Cross Linking C-telopeptide of Type 1 Collagen at 3 Months and 6 Months | At 6 months | 16.318 mcg/L | Standard Deviation 17.1383 |
| Test Product | Change From Baseline in Urinary Cross Linking C-telopeptide of Type 1 Collagen at 3 Months and 6 Months | Change from baseline at 6 months | -6.835 mcg/L | Standard Deviation 22.1252 |
| Test Product | Change From Baseline in Urinary Cross Linking C-telopeptide of Type 1 Collagen at 3 Months and 6 Months | Change from baseline at 3 months | -1.309 mcg/L | Standard Deviation 20.8967 |
| Reference Product | Change From Baseline in Urinary Cross Linking C-telopeptide of Type 1 Collagen at 3 Months and 6 Months | Change from baseline at 6 months | -6.429 mcg/L | Standard Deviation 27.9624 |
| Reference Product | Change From Baseline in Urinary Cross Linking C-telopeptide of Type 1 Collagen at 3 Months and 6 Months | At 3 months | 31.864 mcg/L | Standard Deviation 27.5339 |
| Reference Product | Change From Baseline in Urinary Cross Linking C-telopeptide of Type 1 Collagen at 3 Months and 6 Months | Change from baseline at 3 months | 6.727 mcg/L | Standard Deviation 22.7372 |
| Reference Product | Change From Baseline in Urinary Cross Linking C-telopeptide of Type 1 Collagen at 3 Months and 6 Months | At 6 months | 18.708 mcg/L | Standard Deviation 20.6598 |
| Reference Product | Change From Baseline in Urinary Cross Linking C-telopeptide of Type 1 Collagen at 3 Months and 6 Months | At baseline | 25.137 mcg/L | Standard Deviation 22.8524 |