Part 1: 1000 mg elemental magnesium (given as one 800 mg capsule of magnesium oxide two times daily).
Part 2: 1500 mg elemental magnesium (given as two 500 mg capsules of magnesium oxide in the morning and three 500 mg capsules of magnesium oxide in the evening).

Part 1: 1000 mg (one 500 mg capsule two times daily) of placebo.

Magnesium oxide capsules 800mg twice daily (total of 1000mg of elemental magnesium) for year 1. Upon completion of the first year, barring any safety concerns, all subjects were administered 2500 mg magnesium oxide (total of 1500 mg elemental magnesium) daily for up to one additional year. Subjects received 600 mg elemental magnesium oxide in the morning (taken as two 500 mg magnesium oxide capsules, each containing 300 mg elemental magnesium) and 900 mg elemental magnesium oxide in the evening (taken as three 500 mg magnesium oxide capsules, each containing 300 mg elemental magnesium).

Magnesium Oxide

Placebo year 1. Upon completion of the first year, barring any safety concerns, all subjects were administered 2500 mg magnesium oxide (total of 1500 mg elemental magnesium) daily for up to one additional year. Subjects received 600 mg elemental magnesium oxide in the morning (taken as two 500 mg magnesium oxide capsules, each containing 300 mg elemental magnesium) and 900 mg elemental magnesium oxide in the evening (taken as three 500 mg magnesium oxide capsules, each containing 300 mg elemental magnesium).

Placebo

Total

Sex: Female, Male

Number of participants with low t-score < -1. The T-score is a radiographic diagnosis that compares bone mineral density (BMD) to that of a "normal, healthy, 30-year-old female". The lower the T-score, the lower the BMD. A T-score of +1 to -1 is normal. A T-score decrease of -1 indicates a 10%-15% decrease in BMD.

Bone Mineral Density (BMD)

0 - No evidence of PXE, 1 - Poorly defined, barely visible macules, 2 - Well defined, easily identified macules, 3 - Mostly macules with <5 papules, 4 - >= 5 papules, 5- Patches consisting of confluent macules with <50% of target area covered by papules, 6 - Patches consisting of confluent macules with >=50% of target area covered by papules, 7 - Plaques, 8 - Plaques with mild folds of skin, 9 - Plaques with redundant folds of skin

Peau D'Orange right eye

Peau D'Orange left eye

2- Streaks may be found in association with cardiovascular disease, most commonly of the arterio-sclerotic, hypertensive type 3- Associated with Paget's disease 4- Streaks caused by pigment accumulations and may be termed "secondary"

Angioid Streaks right eye

Angioid Streaks left eye

Subretinal fluid right eye

Subretinal fluid left eye

A blinded dermatopathologist graded skin biopsies on the density of Von Kossa staining, assessed changes in the amount of calcification of elastic fibers by assessing von Kossa staining per unit area of dermis

Von Kossa Staining Per Unit Area of Dermis

Changes in skin skin lesions observed through investigator evaluations and clinical photographs. The number of patients with a 1-point decrease of target lesions

Number of Participants With a 1-point Decrease of Target Lesions

Rate of disease progression - Changes observed through ophthalmologic examinations. (+) a decrease in this score indicates improvement of the disease (-) an increase in this score indicates worsening of the disease. LogMAR: logarithm of the minimum angle of resolution. The LogMAR scale converts the geometric sequence of a traditional chart to a linear scale. It measures visual acuity loss: positive values indicate vision loss, while negative values denote normal or better visual acuity.

LogMar

Rate of disease progression observed through ophthalmologic examinations.(+) an increase in this score indicates improvement of the disease (-) a decrease in this score indicates worsening of the disease. VAS ranges from 10 to 200, with higher score indicating poorer visual acuity.

VAS - Visual Acuity Score

Rate of disease progression observed through ophthalmologic examinations. (+) a decrease in this scores indicates improvement of the disease; (-) an increase in this scores indicates improvement of the disease.

Central Retinal Thickness

Placebo-controlled Period

Open-label Period

Dr. Mark Lebwohl

Pseudoxanthoma Elasticum

1000 mg (one 500 mg capsule two times daily) of placebo.

Icahn School of Medicine at Mount Sinai

Magnesium Supplements In The Treatment Of Pseudoxanthoma Elasticum (PXE)

Mark Lebwohl

Principal Investigator

Postoperative Nausea and Vomiting

Abdominal Pain

5mg po 6 hours postoperatively, repeat in 12 hours if no flatus

Bisacodyl

1 capsule po 6 hours after surgery; repeat in 12 hours if no flatus

mgo/náusea

Magnesium Supplements In The Treatment Of Pseudoxanthoma Elasticum (PXE)

Bisacodyl Use in the Post-operative Care of Obstetrical/Gynecological (OB/GYN) Patients

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