Female postmenopausal subjects with osteopenia and mild to moderate joint discomfort Musculoskeletal Diseases
Conditions
Interventions
The product under investigation is a patented bioactive and bioavailable peptido-mineral complex. Half of the recruited subjects are randomized to receive the active product, while the other half rece
Sponsors
NOVACTIVA
Eligibility
Sex/Gender
Female
Age
50 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Healthy female subjects 2. Caucasian ethnicity 3. Postmenopausal 4. Subjects aged between 50 and 70 years (extremes included) 5. Subjects with osteopenia* 6. Subjects with mild to moderate joint discomfort (not related to any underlying pathology) ** 7. Subjects registered with National Health Service (NHS) 8. Subjects certifying the truthfulness of the personal data disclosed to the investigator 9. Subjects able to understand the language used in the investigation centre and the information given by the investigator 10. Subjects able to respect the instructions given by the investigator as well as able to respect the study constraints and specific requirements 11. Commitment not to change the daily routine or lifestyle 12. Stable pharmacological therapy (except for the pharmacological therapy in the non-inclusion criteria) for at least two months without any changes expected or planned during the study 13. Subjects informed about the test procedures who have signed a consent form and privacy agreement *At the recruitment, T-score between -1,0 and 2,5 (assessed through DEXA analysis on lumbar spine and femoral neck). According to the World Health Organization - WHO: -T-score = -1,0: Normal bone density -T-score between -1,0 and -2,5: Osteopenia ** At the recruitment, Discomfort on palpation (see paragraph 8.7) and Perceived joint discomfort (see paragraph 8.8) scores from 4 to 8 (extremes included)
Exclusion criteria
Exclusion criteria: 1. Subjects who do not meet the inclusion criteria 2. Subjects with any acute, chronic, or progressive disease or condition that may interfere with the study data or that the investigator considers dangerous to the subject or incompatible with the requirements of the study*** 3. Subjects participating or planning to participate in other clinical trials 4. Subjects who participated in a similar study without respecting an adequate washout period (at least 2 months) 5. Subjects that have food intolerances or food allergies to ingredients of the study product 6. Subjects under pharmacological treatments that are considered incompatible with the study requirement by the investigator 7. Subjects who are currently using food supplement(s) and/or products with the same activity as the study product, or who haven't observed an adequate washout period (at least 2 months)**** 8. Subjects admitted to a health or social facility 9. Subjects planning a hospitalization during the study 10. Subjects not able to be contacted in case of emergency 11. Subjects deprived of freedom by administrative or legal decision or under guardianship 12. Subjects who have or have had a history of alcohol or drug addiction 13. Subjects with eating disorders (i.e. bulimia, psychogenic eating disorders, etc) ***Musculoskeletal diseases or skeletal neuromuscular injuries (e.g. advanced osteoarthritis; moderate osteoarthritis with an ongoing inflammatory component, significant mobility impairment, or treated with a joint injection within the past 2 months; recent fractures; neuromuscular disorders affecting mobility), autoimmune diseases (e.g. active rheumatoid arthritis, systemic lupus erythematosus; ankylosing spondylitis; polymyalgia rheumatica; psoriatic arthritis), neurological or psychiatric disorders (e.g. multiple sclerosis; Parkinson’s disease; major depression; schizophrenia). ****Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) (Occasional use will be tolerated, with a maximum of two tablets per month. Participants will be required to maintain a diary documenting medication use), systemic corticosteroids, pain medications taken daily or on a regular basis, anti-osteoporosis treatment, medications affecting bone or cartilage metabolism (e.g. bisphosphonates, denosumab), intra-articular injections of hyaluronic acid, triamcinolone, or methylprednisolone within the past 2 months, Hormonal Replacement Therapy (e.g. estrogen or estrogen-progestin therapy), parathyroid hormone analogues.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. T-score obtained through DEXA - lumbar spine (g/cm²) at baseline, and after 168 days and 336 days of treatment 2. T-score obtained through DEXA - femoral neck (g/cm²) at baseline, and after 168 days and 336 days of treatment 3. CTX (C-terminal telopeptide of type I collagen) (pg/ml) at baseline, and after 84 days, 168 days and 336 days of treatment 4. P1NP (Procollagen Type I N-Terminal Propeptide) (pg/ml) at baseline, and after 84 days, 168 days and 336 days of treatment 5. Passive range of motion (PROM) (°) at baseline, and after 28 days and 84 days of treatment 6. Active range of motion (AROM) (°) at baseline, and after 28 days and 84 days of treatment 7. Discomfort on palpation (Score from 0 to 10) at baseline, and after 28 days and 84 days of treatment 8. Perceived joint discomfort (Score from 0 to 10) at baseline, and after 28 days and 84 days of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-evaluation questionnaire (polytomous question with four possible answers) after 336 days of treatment | — |
Countries
Italy
Contacts
Public ContactRoberta Villa
Outcome results
None listed