In short
This article discusses the use of Calcium Lactate Gluconate, a form of calcium, in clinical trials for the treatment of post-menopausal osteoporosis. While the main focus of the trial is on a different drug (BP16), Calcium Lactate Gluconate is included as part of the study medication. The trial aims to compare the effectiveness, safety, and other factors of BP16 with an existing treatment (EU-Prolia) in women with post-menopausal osteoporosis.
At a glance
- Study Type
- Phase III, Randomized, Double-Blind, Parallel Group, Multicenter Study
- Main Condition
- Post-Menopausal Osteoporosis
- Primary Objectives
- Compare BP16 and EU-Prolia in terms of bone mineral density change and serum C-telopeptide levels
- Key Inclusion Criteria
- Post-menopausal women, 55-80 years old, T-score between -2.5 and -4.0 at lumbar spine
- Study Duration
- 78 weeks
- Primary Endpoints
- Percent change in lumbar spine bone mineral density at Week 52, AUEC of sCTX from Week 0 to Week 26
- Calcium Lactate Gluconate Role
- Included as part of study medication, likely as a calcium supplement
What is Calcium Lactate Gluconate?
Calcium Lactate Gluconate is a calcium supplement that is used to prevent or treat low calcium levels in the body. It's also known as calcium lactogluconate. This compound is a combination of calcium, lactic acid, and gluconic acid, which helps in better absorption of calcium in the body.
Medical Uses
While the primary focus of the clinical trial data is on a different medication (denosumab), it provides context for conditions where calcium supplements might be beneficial. The main condition mentioned is:
- Post-Menopausal Osteoporosis: This is a condition where bones become weak and brittle, primarily in women after menopause. Calcium supplements, including Calcium Lactate Gluconate, can be crucial in managing this condition.
Calcium supplements are generally used to:
- Prevent or treat calcium deficiencies
- Support bone health
- Aid in the prevention of osteoporosis
Composition
The clinical trial data mentions a product that contains Calcium Lactate Gluconate along with other substances. The composition includes:
- Calcium Lactate Gluconate: The primary calcium source.
- Calcium Carbonate: Another form of calcium, also known as chalk.
- Ascorbic Acid: Also known as Vitamin C, which can aid in calcium absorption.
Administration
According to the clinical trial data, the medication containing Calcium Lactate Gluconate is administered orally. The maximum daily dose amount is listed as 2 grams, with a maximum total dose amount of 1148 grams over a treatment period of 82 weeks.
Clinical Trial Information
While the clinical trial described in the data is not specifically about Calcium Lactate Gluconate, it provides context for research in the field of osteoporosis treatment. The trial is comparing a medication called BP16 with EU-Prolia® (denosumab) in post-menopausal women with osteoporosis.
Potential Benefits
While not directly studied in this trial, calcium supplements like Calcium Lactate Gluconate can potentially offer the following benefits:
- Improved bone mineral density
- Reduced risk of fractures
- Support for overall bone health
Safety Considerations
As with any medication or supplement, it's important to consider safety. While the trial data doesn't provide specific safety information for Calcium Lactate Gluconate, general considerations for calcium supplements include:
- Potential interactions with other medications
- Possible side effects such as constipation or stomach upset
- The importance of not exceeding recommended doses
Always consult with your healthcare provider before starting any new supplement regimen, including Calcium Lactate Gluconate.